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BOSTON 

PUBLIC 
tlBRftRY 




ORGAN TRANSPLANTS 



HEARINGS 

BEFORE THE 

SUBCOMMITTEE ON 
INVESTIGATIONS AND OVERSIGHT 

OF THE 

COMMITTEE ON 

SCIENCE AND TECHNOLOGY 

U.S. HOUSE OF REPRESENTATIVES 

NINETY-EIGHTH CONGRESS 

FIRST SESSION 



APRIL 13, 14, 27, 1983 



[No. 16] 



Printed for the use of the 
Committee on Science and Technology 




»- 



ORGAN TRANSPLANTS 









HEARINGS 

BEFORE THE 

SUBCOMMITTEE ON 
INVESTIGATIONS AND OVERSIGHT 

OF THE 

COMMITTEE ON 

SCIENCE AND TECHNOLOGY 

U.S. HOUSE OF REPRESENTATIVES 

NINETY-EIGHTH CONGRESS 

FIRST SESSION 



APRIL 13, 14, 27, 1983 



[No. 16] 



Printed for the use of the 
Committee on Science and Technology 




23-029 O 



U.S. GOVERNMENT PRINTING OFFICE 
WASHINGTON : 1983 



For sale by the Superintendent of Documents, U.S. Government Printing Office 
Washington, D.C. 20402 



COMMITTEE ON SCIENCE AND TECHNOLOGY 



DON FUQUA, Florida. Chairman 



ROBERT A. ROE, New Jersey 
GEORGE E. BROWN, Jr., California 
JAMES H. SCHEUER, New York 
RICHARD L. OTTINGER, New York 
TOM HARKIN, Iowa 
MARILYN LLOYD, Tennessee 
DOUG WALGREN, Pennsylvania 
DAN GLICKMAN, Kansas 
ALBERT GORE, Jr., Tennessee 
ROBERT A. YOUNG, Missouri 
HAROLD L. VOLKMER, Missouri 
BILL NELSON, Florida 
STAN LUNDINE, New York 
RALPH M. HALL, Texas 
DAVE McCURDY, Oklahoma 
MERVYN M. DYMALLY, California 
PAUL SIMON, Illinois 
NORMAN Y. MINETA, California 
RICHARD J. DURBIN, Illinois 
MICHAEL A. ANDREWS, Texas 
BUDDY MacKAY, Florida 
TIM VALENTINE, North Carolina 
HARRY M. REID, Nevada 
ROBERT G. TORRICELLI, New Jersey 
FREDERICK C. BOUCHER, Virginia 

J. H. Poore, Executive Director 

Robert C. Ketcham, General Counsel 

Regina A. Davis, Administrator 

David S. Jeffery, Minority Staff Director 



LARRY WINN, Jr., Kansas 
MANUEL LUJAN, Jr., New Mexico 
ROBERT S. WALKER, Pennsylvania 
WILLIAM CARNEY, New York 
F. JAMES SENSENBRENNER, Jr., 

Wisconsin 
JUDD GREGG, New Hampshire 
RAYMOND J. McGRATH, New York 
JOE SKEEN, New Mexico 
CLAUDINE SCHNEIDER, Rhode Island 
BILL LOWERY, California 
ROD CHANDLER, Washington 
HERBERT H. BATEMAN, Virginia 
SHERWOOD L. BOEHLERT, New York 
ALFRED A. (AD McCANDLESS, California 
TOM LEWIS, Florida 






Subcommittee on Investigations and Oversight 



ALBERT GORE, Jr., 

HARRY M. REID, Nevada 
HAROLD L. VOLKMER, Missouri 
ROBERT A. ROE, New Jersey 
RICHARD J. DURBIN, Illinois 
JAMES H. SCHEUER, New York 



Tennessee, Chairman 

JOE SKEEN, New Mexico 

ALFRED A. (ALJ McCANDLESS, California 

CLAUDINE SCHNEIDER, Rhode Island 



Robert B. Nicholas, Chief Counsel/Staff Director 

Steven A. Owens, Counsel 

James E. Jensen, Investigator 

Donald L. Rheem, III, Minority Technical Consultant 



(II) 



CONTENTS 



WITNESSES 



April 13, 1983: 

H< Ten?e a sse 1 e d E ' F ° rd ' * Representative in Congress from the State of Page 

Bi IL ie ^j 1 ' With S T ° n ' **%$? Haili'Capt- Jo^'a BlSric£'^ift"di^ii: 
tor, Adriane; James Williams, M.D., associate professor of surgery, 
University of Tennessee College of Medicine, Memphis, Tenn.; and 
Cxary Hall transplant coordinator, University of Tennessee College of 
Medicine, Memphis, Tenn s fi 

School of Medicine, Stanford, Calif.; Thomas E. Starzl, M.D., professor 
of surgery, University of Pittsburgh School of Medicine, Pittsburgh, 
Pa.; and G Melvil e Williams, M.D., professor of surgery Johns Hop- 
kins Hospital, Baltimore, Md jr,wumu.XMjp 

Donald W. Denny director of organ procurement,' 'transplantation' 'office; 
W S Vn Pltts ^rgh School of Medicine, Pittsburgh, Pa, William 
W. Ptaff, M.D past president Southeast Organ Procurement Founda- 
tion, University of Florida College of Medicine, department of surgery 
alertfwar^ick Rf 11 Raym0nd Coleman > founding president, donor 

April 14, 1983: ' 126 

H Mas'sachu I s e a tte ey ' * Representative in the Congress from the State of 

Michele Jones, kidney transplant recipient; David Ogden, M.D., profes- 
sor of medicine, chief, renal section, University of Arizona Health 

H,wT C A enter; and T Thel ™ King Thiel, vice chairman and executive 
director, American Liver Foundation. 919 

fn X r a thf^°/ gan f ^ r ° n ,' Executive Director, Presidents' Commission 
R.W 1 p y ° f Ethical Problems in Medicine and Biomedical and 
Behavioral Research; Dr James Childress, professor of religious studies 
Un1vPrS e v SS n f r v medlcal education, department of religious studies, 
University of Virginia; and Dr. Robert M. Veatch, professor of medical 
town Universit 1 " 6363 scholar ' Kennedy Institute of Ethics, George- 

Da £ d Rnf ki ^' IP"' o^'^he7chie'Fmedic^ 281 

ppn'tPr C^i ? Va ^f' , res ^ arc ^ scientist, health and population study 
ft. le r InS f tltut6 ' S % at $ e ' Wash ' ; and John McCabe, legal coun- 

Chic o 111 Conference of Commissioners on Uniform State Laws, 

April 27, 1983:' 374 

^S^^^J^^s^' Secretary for Health ' Department 499 

C. Everett Koop, M.D Surgeon General, U.S. Public H^ih&iriceZZZ 514 
Carolyne K. Davis Administrator, Health Care Financing Administra- 
turn; accompanied by Dr. Donald Young .... 591 

£ • " ? e £ ry 'l U ' MD ;. Acting Assistant Secretary of Defense [health 
aitairs], Department of Defense; accompanied by Alexander Rodriquez, 
M.D medical director O-Champus; and Robert L. Gilliat, Esq., Assist- 
Defense 1161 " 3 ° Unsel t man P° w er and health affairs], Department of 

Hon. Dale Bumpers, a U.S.' Senator i^m"the Stete of Aribixis^s"'.;;!!;;!;!;;;;;;;; 588 

(Hi) 



IV 

April 27, 1983— Continued 

Dr. H. David Banta, M.D., Assistant Director for Health and Life Sci- Page 
ences, Office of Technology Assessment 591 

Kenneth W. Sell, M.D., Ph. D., American Association of Tissue Banks 637 

Peter Safar, M.D., university professor and director of resuscitation re- 
search center, University of Pittsburgh 647 

Dr. Richard A. Rettig, professor and chairman, department of social 
sciences, Illinois Institute of Technology 696 

Dr. Jeffrey M. Prottas, visiting professor, center for health policy analysis 
and research, Florence Heller Graduate School, Brandeis University 709 

Winifred B. Mack, president, North American Transplant Coordinators 

Orcra, ization, SUNY at Stony Brook 752 

Appenc^.-v. Additional material submitted for the record 769 



ORGAN TRANSPLANTS 



WEDNESDAY, APRIL 13, 1983 

House of Representatives, 
Committee on Science and Technology, 
Subcommittee on Investigations and Oversight, 
„,, , Washington, D.C. 

9 J? e p SU K COmi £ ttee m j*> Pursuant to call, at 10 a.m., in room 
2325, Rayburn House Office Building, Hon. Albert Gore, Jr. (chair- 
man of the subcommittee) presiding. 
Mr. Gore. The subcommittee will come to order 
I would like to welcome all of our witnesses and guests 

pJ wiTi! 71111 * u, he subco ™ m . ittee be ^ ns 3 da y g of hearings to 
evaluate the problems in obtaining organs for transplant surgery. 
Each of us has been moved by the stories of families seeking life- 
savings organs for their critically ill loved ones. And no sooner has 
one family s plight been resolved, when it seems as if another, and 
then another, comes forth to stand in their place 

I am sure that many of you have wondered, as I have, why there 
isn t some system to help meet these compelling needs in a more 
rational way. Certainly there has to be a better way than relying 
on bursts of media publicity during what is an emotionally difficult 
time for the patient s family. It was for this very reason, especially 
H^LiT P er K sonall y contacted to assist in such a search" that I 
directed the subcommittee staff to conduct the investigation which 
has brought us here today. 

n Jl WiU n ° d ° ubt ? 0me M a sur Prise to many of us here that some 
organ procurement systems are already in place. These systems 

Th£ ?i tiaUy d T evel0ped by local sur ^ cal tea ™ to find transplant- 
Pnn1n^h eyS> In man y. ca ses, these local agencies were poorly 
Xnflv t Z anSW f r f hB ™ reasm 8 demands for kidneys and, more 
recently, demands for other organs brought about by the great 
strides in transplant surgery. We will hear this morning from iome 
?o tm t °^ ai t P r ° cu . rement . agencies who have struggled valiantly 
to fill a constantly increasing demand for transplantable organs, 
trli 1 ?? 1 ^ m ° St ei ? m t n t Panel of surgical pioneers who will de- 
scribe the advances in this life-saving area of science. 
^or!L lr0ny ° ^he problem facing us, as we look at the present 
shortage of available transplantable organs, is that we have a 
flwSSL 0f A °/ gans ™ the face . of Plenty. Let me cite some figures to 
n wS P n eSe £> approximately 5,000 kidneys are being trans- 

fc 1 T^ aUy - ? 1Ve t} \ ousands P^ents who are suitabll candi- 
s«vfL hLi dney * rans PJ ants are currently maintained on life- 
saving dialysis waiting for a suitable kidney. The potential life 



quality improvements for these patients from successful transplant 
surgery and the cost savings potential are enormous. 

A similar situaton exists for liver transplants. Dr. Starzl— from 
whom we will hear shortly— and his group at the University of 
Pittsburgh have performed 111 liver transplants in the 2-year 
period ending in January. Let me correct that and make it 112 be- 
cause Dr. Starzl has been up all night transplanting yet another 
liver, and comes to this hearing room from the operating room. 
During this same time span, another 54 patients died while waiting 
for a donor liver. 

Artificial hearts may, in time, provide hope for those thousands 
who could benefit from a heart transplant— currently there are 100 
heart transplants per year — but development of artificial livers, 
kidneys, and organs of similar complexity are many, many years 
away. 

An estimated 20,000 Americans will die this year from head inju- 
ries, brain tumors, and other circumstances that leave organs 
usable for transplantation. Only a small percentage of those people 
actually donate their organs, even though a Gallup poll taken some 
years ago indicated that 70 percent of all Americans were willing 
to have their organs donated for transplantation at the time of 
death. 

Relatively few people actually sign a donor card or some other 
designated document for organ donation. In Maryland, for exam- 
ple, where the donor card is placed on the back of the driver's li- 
cense, a recent survey showed that only 1.5 percent participated. 
Nationally, what is the net result of this disparity between pro- 
fessed intention and actual action by potential donors? Figures 
from a Center for Disease Control study— which we will also hear 
about today — found that 2 percent of the patients who die in 
American hospitals could be considered suitable donors, yet organs 
are actually being obtained from less than one-fifth of those poten- 
tial donors. 

Testimony during the next 2 days — and then on the third day, 
April 27— will describe the efforts of those who toil in this field. We 
will be hearing from experts in organ procurement and donor so- 
licitation efforts, as well as from some of the families who have had 
direct experience with the system. We will also hear testimony 
from expert witnesses who will discuss the bioethical and legal 
issues involved. On the third and final day, we will hear from the 
Department of Health and Human Services and from a variety of 
witnesses who will suggest changes to improve the present systems. 

I am extremely hopeful that these hearings will provide a focal 
point for improvements in the process and procedures for obtaining 
organs for transplantation so that families will no longer feel com- 
pelled to mount a solitary nationwide campaign. 

I want to call on my colleagues for opening statements, but let 
me note first that we are going to have a change in the sequence of 
the panels. Panel 2 is going to come first — Mrs. Billie Hall with her 
son, Brandon, age 13 months; Dr. James Williams, associate profes- 
sor of surgery at the University of Tennessee, Memphis; Mr. Gary 
Hall, transplant coordinator at the University of Tennessee, Mem- 
phis; and Capt. John H. Broderick, and Mrs. John Broderick, with 
their daughter, Adriane, age 28 months from Minden, La. 



The reason for the change is good news, happy news. The long- 
awaited donor for Brandon Hall was located at 7 a.m. this morning. 
Mrs. Hall and her son will be flying back to Tennessee, along with 
Dr. Williams and Gary Hall, for surgery this afternoon. It is a very 
happy announcement. We are delighted you can be here with us 
for a short time before you have to go. We are going to change the 
panels for that reason. 

Let me call on the ranking minority member of this subcommit- 
tee, Mr. Skeen. 

Mr. Skeen. Thank you very much, Mr. Chairman. 

The 3 days of hearings beginning today take the subcommittee 
into one of the most impressive areas of recent scientific break- 
throughs. Nowhere is the human drama surrounding science great- 
er than it is for organ transplants. The fate of waiting organ recipi- 
ents, hoping that somewhere in the United States someone with 
matched organ characteristics has had the vision and the charity 
to provide for the donation of their organs after death, is always a 
poignant story. 

I know, because my niece, who will be testifying tomorrow, has 
recently undergone kidney transplant surgery after 3 years of bi- 
weekly dialysis treatments. I know the pain and trauma of adjust- 
ing to a lifestyle completely dependent on a machine. I am learning 
now, 2 months after Michelle's surgery, how the recent break- 
through in transplant technology can make a bright and hopeful 
new life from one burdened with debilitating medical treatments or 
death. 

Let me congratulate and express my gratitude to those members 
of the medical community with us during our hearings for bringing 
us to the point we are today. It seems such a short time ago that I 
lost my sister to glomerulonephritis. She died in 1962; she was 28 
years old. There were no options then, despite the best attention of 
the medical profession. There simply wasn't anything they could 
do. 

The situation is illustrative of the rate or pace of change current- 
ly underway in the scientific community. We are seeing it more 
and more on this committee as major breakthroughs occur almost 
every day. In less than two generations, we have progressed from a 
situation where someone such as my sister was left with no option 
but death, to the situation today where my niece, Michelle, has the 
option of life either by machine or by transplant surgery. Certainly 
there is a lot to be grateful for, and much more to look forward to. 

The key to what some observers are referring to as a Renais- 
sance in transplant surgery is the drug cyclosporine. First used in 
Great Britain in 1978, this drug fights the body's rejection of trans- 
planted organs, thereby improving the 1-year survival rate. The 
chances for successful transplants for such organs as heart, lung, 
kidney, and liver have more than doubled in the last 5 years. 

With the improvements in surgical techniques and new drugs, 
over 5,000 people benefited from organ transplants in 1981. The 
number is growing all the time, and more organ recipients are ex- 
periencing successful transplants. The future of this field of re- 
search is, in my opinion, without limit. A decade from now, we will 
find a medical community capable of major feats of not only trans- 



planting organs, but of reconstructing damaged ones as well. The 
benefits to many Americans will be truly astounding. 

Our subcommittee applauds all of our witnesses, doctors, and pa- 
tients alike, and we welcome you to Washington. We also bid you 
farewell if you need to get out of here for that transplant today, 
and we appreciate your time that you have given us. It is my hope 
that we might be able to listen to you in these 3 days and find 
some way to help this process along. Most of the networking for 
organ donors and recipients has been from the ground up, and the 
support organizations you now have are very impressive. If you 
think the Federal Government can help, I would like to hear about 
it. Under the leadership of our chairman, Mr. Gore, I am confident 
that the subcommittee will take the necessary and proper steps to 
aid in this progress. 

Thank you, Mr. Chairman. 

Mr. Gore. Thank you very much. 

Congressman Scheuer has an opening statement. 

Mr. Scheuer. Thank you, Mr. Chairman. I will make it brief. I 
know we are all eager to get to the witnesses. 

We are at a wonderful point in time. I want to thank you for 
your leadership in bringing us all together. These transplants that 
were once unthinkable are now a practical therapeutic alternative 
to such expensive and life debilitating procedures as renal dialysis. 
Now the transplant technology is here to stay, thanks to the drug 
cyclosporine that has apparently solved the rejection problems. 

We in Congress must evaluate and analyze how the Federal Gov- 
ernment can aid in organ procurement and how we can make sure 
that every patient who needs an organ for a transplant has one. 
We must also examine the adequacy of the medicare coverage for 
transplants, both in terms of the procedures and the length of time 
that the benefits are available. 

In no way should the Federal reimbursement mechanism act as 
a disincentive to transplants which are far more live-saving, far 
more live-enhancing, and far cost effective than conventional ther- 
apies. 

Let me congratulate you again on scheduling this remarkable 
hearing, Mr. Chairman. 

Mr. Gore. Thank you very much. 

Congresswoman Schneider. 

Mrs. Schneider. I would like to thank you, Mr. Chairman, for or- 
ganizing and pulling together what I think is a very timely and in- 
teresting hearing. I think all we need to do is to look at the news- 
papers or turn on the television set and see the remarkable ad- 
vances that have occurred in the area of organ transplants. 

The thought of vital organs, such as livers, hearts, and kidneys, 
being transplanted routinely at our Nation's best medical centers is 
a tribute to how far transplant technology has evolved since its 
earliest days a decade and a half ago. The works of Doctors Shum- 
way, Starzl, and Williams — to name some of the leaders — combined 
with the R&D of the pharmaceutical industry in perfecting a pow- 
erful, yet safe and practical drug, cyclosporine, demonstrates great 
hope and promise of modern medicine. 

Now that the medical technology is so very advanced, we have to 
make certain that its support system in terms of organ procure- 



ment keeps pace. One of the witnesses later today, I am proud to 
say, is from my State of Rhode Island, and very actively involved in 
helping connect the supply with demand. I think it would certainly 
be a tragedy if, after realizing that we have the technological 
breakthrough medically and pharmaceutically, that we don't take 
full advantage by affording this remarkable therapy to all needy 
patients. 

I feel certain that, through the work of the subcommittee and 
elsewhere in Congress, we can have a very meaningful impact on 
the availability of transplant surgery, and I look forward to the tes- 
timony of our distinguished witnesses at this morning's hearing. 

Thank you very much. 

Mr. Gore. Thank you very much. 

Mrs. Hall, if you and Brandon could come to the witness table. 
We are delighted to have you here. Captain Broderick, I would like 
you and Adriane to join them at the center of the table there. Dr. 
Williams, you are already at the witness table. Mr. Hall, if you 
could join us as well. 

By way of introduction, let me say that Mrs. Billie Hall lives in 
Walnut, Miss., with her son, Brandon, age 13 months. Brandon has 
been awaiting a liver transplant for quite a long time now. As I 
mentioned before, there was happy news just this morning which 
will take Mrs. Hall and Dr. Williams and Mr. Gary Hall back to 
Tennessee. 

Capt. John Broderick and his daughter, Adriane, age 28 months, 
live in Minden, La. They are also patients at the UT Health Center 
with Dr. Williams, who is joining us. We also have Gary Hall, who 
is the transplant coordinator at the University of Tennessee. 

To introduce our Tennessee witnesses, I am honored to recognize 
our distinguished colleague, Congressman Harold Ford. 

STATEMENT OF HON. HAROLD E. FORD, A REPRESENTATIVE IN 
CONGRESS FROM THE STATE OF TENNESSEE 

Mr. Ford. Thank you very much, Mr. Chairman and other mem- 
bers of the subcommittee, for your kind words and for granting me 
the opportunity to introduce two distinguished professionals from 
the great State of Tennessee and from my district at the Medical 
Center. 

Before I continue my introduction of our Tennessee guests, let 
me say that I, too, am cognizant of the fact that there are problems 
related to the organ procurement for transplants. Not long ago, my 
office in Memphis, Tenn., was contacted by our local media to help 
in the search for a liver donor for a child hospitalized in my dis- 
trict. I was shocked and dismayed to learn that a media campaign 
of that magnitude had to be launched in order to procure a suit- 
able donor. 

I commend both Chairman Gore and the Committee on Science 
and Technology for this hearing today and for this subcommittee 
taking the time out of its busy schedule to arouse the awareness 
from the congressional standpoint, as well as public awareness, of 
the problems associated with organ procurement for transplants. 

The University of Tennessee's Center for Health Sciences has 
made a giant stride in the science of organ transplants. It is one of 



the three major centers engaged in liver transplants, and the only 
designated kidney transplant center in west Tennessee. Since May 
19, 1982, when the center conducted its first liver transplant, seven 
other transplants have been successful in that medical center. 

It is my distinct pleasure to introduce Dr. James W. Williams, 
who heads the surgical team at the University of Tennessee that 
has performed five liver transplants since last May; and Mr. Gary 
Hall, the university's transplant coordinator. Without the invalu- 
able services and knowledge of these two professionals, much of the 
progress that we have made in our hometown would not be there. 
We are proud today to have the two before this subcommittee in 
the Congress. 

Once again, let me say that it is my sincere pleasure to introduce 
them, and to know that we do have a donor as of 7 o'clock this 
morning for the son of Mrs. Hall. 

Thank you, Mr. Chairman and the members of this subcommit- 
tee. 

Mr. Gore. Thank you very much, Congressman. 

We want to hear first from Mrs. Billie Hall. Mrs. Hall, I know 
this is a dramatic day for you. It is our hope, as I know it is yours, 
that the experience you have been through will be of some benefit 
to others who will be undergoing the same challenge of finding a 
donor for a child who needs an organ to live. We are delighted to 
have you here on this special day. If you could share some thoughts 
with us, we would appreciate it. 

STATEMENTS OF BILLIE HALL, WITH SON, BRANDON HALL; 
CAPT. JOHN H. BRODERICK, WITH DAUGHTER, ADRIANE; 
JAMES WILLIAMS, M.D., ASSOCIATE PROFESSOR OF SURGERY, 
UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE, MEM- 
PHIS, TENN.; AND GARY HALL, TRANSPLANT COORDINATOR, 
UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE, MEM- 
PHIS, TENN. 

Mrs. Billie Hall. Thank you very much for having us. I thank 
you not only for Brandon, but for everybody else who is here with 
children that have Brandon's problems. 

I would like to tell you a few things that happened to Brandon 
over the last 13 months. Brandon was 2 weeks old when we found 
out that he has biliary atresia. He had surgery at that time, and 
they were hoping that the surgery that they did would correct the 
problem long enough, at least until he could get big enough for a 
transplant. 

He did fine for 3 or 4 months, and then he started having bleed- 
ing problems around his stomach. Dr. Whittington, Brandon's 
doctor, told me that to live, Brandon would have to have a trans- 
plant. He told us that we would have to have so much money to get 
Brandon in the hospital. Brandon has SSI, and I don't have any in- 
surance. He told me that medicaid would not pay. So, we were 
faced with another problem. We had to get at least $30,000 togeth- 
er to get Brandon in the hospital. 

We have a small religious radio station in Walnut, and they got 
behind us, and we worked for 5 months and raised $81,000. We 
were fortunate. God was with us. There are so many people who 



won't be as fortunate as we have been. There needs to be some- 
thing done about the medicaid helping these children. It is so terri- 
ble to see a child die because they do not have the money to pay 
for getting help for their child. We did raise the money. 

In December, Brandon started losing weight. He was going down 
every day. They were afraid they were going to have to put him on 
the list for a donor then. But we started feeding him with NG-2 
and he gained weight back up to 19 pounds. We thought we were 
in good shape then, but he started retaining fluid. He just started 
doing real bad. 

I am sorry. 

Mr. Gore. That is all right. 

Mrs. Billie Hall. This is a good day. 

Mr. Gore. It is an emotional day. We understand. 

Mrs. Billie Hall. Brandon's birthday was in March. The week 
after his birthday, Dr. Williams and Dr. Whittington put Brandon 
on the search list for a liver. They thought at that time that he 
had 1 month or maybe 2 months before he would need the donor. 
So, they weren't pushing it. They just had him on the search list. 

A couple of weeks ago, Brandon started retaining fluid again and 
running a fever and just having several recurring things happen- 
ing to him, like the fluid and everything. So, they put him on the 
rush list. They put him on top priority for a donor. 

Thank God, this morning we did get one. We are one of the very 
few that are so fortunate to find a donor. There needs to be so 
much more public awareness. Until people know the need for these 
children, we are going to have these problems. We have had so 
many people behind us, so we are very fortunate. You can look 
around. There are so many people here with children just like 
Brandon that needs the surgery just as bad as my son does. 

If there is anything that can be done to help to make more 
public awareness or get a better system set up, we do need it. They 
need it. We have got ours. With God's help, we are going to make 
it. But there are so many here who might now. So, please, if there 
is anything that you can do to help these others, we would appreci- 
ate it so much. 

Thank you. 

Mr. Gore. Thank you, Mrs. Hall. 

When these hearings were announced, we found that a lot of 
people came with children who we didn't expect to come. But there 
are a number of mothers and fathers with children who came to 
these hearings for precisely the reasons you just outlined. 

Our next witness is the father of a young child, Adriane, age 28 
months, who is awaiting a transplant. Captain Broderick, we all 
wish that you and your family could share in the joy that Mrs. 
Hall feels this morning. The sharp disparity between the two expe- 
riences you all are having today points up again the need for a na- 
tionwide rational system to help families in this distress out. So, we 
would be delighted to hear from you, Captain Broderick. 

Captain Broderick. Thank you. 

I have a short statement. 

Mr. Gore. Captain Broderick, let me say for the record that you 
are a captain on active duty in the U.S. Army; is that correct? 

Captain Broderick. Yes, sir. 



8 

Mr. Gore. You are stationed where? 

Captain Broderick. Louisiana Army Ammunition Plant. 

Mr. Gore. Thank you very much. Please proceed. 

Captain Broderick. Our daughter, Adriane is now 28 months old 
and has biliary atresia. She was born November 30, 1980, in 
Athens, Greece. She also exhibited jaundice on birth. Unfortunate- 
ly, because of the environment we were in, it was not discovered as 
quickly as Brandon's. She was flown to a military hospital in Ger- 
many where the possibility of biliary atresia was diagnosed. Her 
military physicians at that time were not very optimistic regarding 
her survival, and indicated she would probably die within several 
months without major surgery. 

She was then transferred to Walter Reed Army Medical Center 
where additional tests confirmed the diagnosis of biliary atresia. 
Since the Army medical system at that time could not perform the 
corrective surgery, she was transferred to Children's Hospital Na- 
tional Medical Center in Washington, D.C., in February 1981. 

There it was decided a Kasai procedure would be necessary in 
order to find bile ducts large enough to prevent her liver from dys- 
functioning and allow bile flow. At that time, she only had a 50- 
percent chance of success. The operation was performed by Dr. 
Kathryn Anderson. After some complications, she responded to the 
surgery and was released in March 1981. 

I was then stationed in Alabama, and her condition again began 
to deteriorate in April. As a result, she was admitted to Vanderbilt 
University Medical Center in May. Dr. Wallace Neblett revised the 
original Kasai procedure, but the advancing cirrhosis she developed 
made the operation very difficult. Her prognosis upon release was 
poor. It was felt her liver would fail, and she would die within a 
year. 

She suffered increased bleeding from a portoenterostomy in 
June, and was again readmitted to Vanderbilt for additional sur- 
gery in February 1982. 

After she was released, she was followed by numerous military 
and civilian physicians in an attempt to stabilize or delay the ad- 
vancing deterioration of her liver. 

In August 1982, after examination by Dr. John Andersen of the 
University of Texas Health Science Center at Dallas, the possibility 
of a liver transplant was discussed as the only way to save her life. 

We then traveled to the University of Tennessee Center for the 
Health Sciences in Memphis. At that time it was one of the few 
centers doing transplants. Dr. James W. Williams confirmed her 
prognosis, and suggested Adriane would be an ideal candidate for a 
liver transplant. After a long period of hopelessness, watching her 
slowly die from this disease, a transplant gave us our first hope for 
her continued survival. 

Little did we know that her continually deteriorating medical 
condition and the difficulty in finding a suitable organ for trans- 
plantation were not the only obstacles to overcome in saving her 
life. 

As an active-duty member of the Armed Forces, CHAMPUS [Ci- 
vilian Health and Medical Program for the Uniformed Services] is 
responsible for providing medical care for my family if the normal 
military medical system cannot provide that care. After allowing 



coverage for three major operations, we were surprised to learn 
CHAMPUS would only pay for her to die in a hospital and not for 
the liver transplant which would save her life. If at any point a 
transplant was necessary, I was personally responsible for the bills. 

Since $65,000 is the cost of admittance for the hospital doing the 
transplant, my only available means of getting the necessary funds 
to save my daughter's life would be public fundraising or medicaid. 
Further investigation revealed three reasons why my daughter's 
medical condition was disallowed by CHAMPUS. 

The first is, since there are a limited number of centers who are 
actively doing the procedure, liver transplantation cannot be readi- 
ly replicated, nor be provided with a predicted level of success at a 
significant number of facilities and, therefore, it does not meet the 
generally accepted standards of usual professional medical practice 
in the general medical community. 

The question as to whether this procedure is routine is not for 
me to answer, but I assume the testimony the physicians from the 
various centers will give will adequately demonstrate that liver 
transplantation is an accepted standard of usual professional medi- 
cal practice for treatment of severe liver dysfunction. 

The second consideration is that other federally funded health 
programs, as well as other third-party payers also consider the pro- 
cedure to be investigational. 

Based upon my research and the research of others, this is based 
upon an outdated National Institutes of Health survey conducted 
in October 1980, which states the liver transplant success rate is 
approximately 38 percent. This survey was prior to the use of cyclo- 
sporine A, and only mentions cyclosporine A as being used in limit- 
ed human trials, specifically Dr. Starzl's work. The success rate is 
obviously higher. As far as other federally funded health programs, 
I have received limited Massachusetts medicaid coverage because 
of Senator Kennedy's personnel's efforts. And it is my understand- 
ing numerous States like New York and Pennsylvania consider 
liver transplants therapeutic. 

From my own experience, the University of Tennessee has in- 
formed me the only major insurance carrier who has not provided 
coverage at that hospital is CHAMPUS. 

The final consideration is the high cost of the procedure, typical- 
ly $50,000 to $60,000, versus the expected long-range benefit to be 
derived. I, personally, find this argument repugnant, since it de 
facto has set a dollar value to my daughter's life. It would appear 
CHAMPUS is all too willing to pay for her to die, at a greater cost 
than for her to live. The expected long-range benefit is her life. If 
economics is the consideration, then the transplant is cost effective, 
a position reinforced by the Surgeon General of the United States. 

There are three hurdles in my opinion that we have to overcome. 
The first is finding the funds to get your child into the hospital; the 
second — obviously Brandon has met that hurdle — is finding a liver; 
the third — typified by Jamie Fiske — is surviving the actual sur- 
gery. 

Why is the reimbursement issue important to us? Without the 
funds to gain admittance, I cannot even achieve the first hurdle. 

In conclusion, Adriane is still suffering from the debilitating ef- 
fects of her biliary atresia, and ultimately she will succumb to liver 



10 

failure, probably within 18 months. She does have hope for contin- 
ued survival with a good quality of life if she receives a successful 
liver transplant. This, of course, is dependent upon our ability to 
afford the operation. 

Your recommendations that liver transplantation is not investi- 
gational, combined with improved methods of organ procurement, 
and the legislation currently in Congress which allows widespread 
acceptance of the procedure, can save numerous lives from liver 
disease — possibly Adriane's. 

That concludes my oral testimony, sir. 

Mr. Gore. Captain Broderick, so I understand your testimony, 
before we complete the panel, CHAMPUS is the health plan pro- 
vided by the U.S. Government to active-duty members of the mili- 
tary, and the U.S. Government, through CHAMPUS, has refused to 
pay for your daughter's liver transplant, in part because it would 
cost $50,000 to $60,000; is that correct? 

Captain Broderick. Yes, sir. 

Mr. Gore. We will certainly have some questions about that 
when the panel has concluded. 

[The prepared statement of Captain Broderick follows:] 



11 



Our daughter, Adriane is now 28 months old and has biliary atresia. She 
was born November 30, 1980 in Athens, Greece. Her jaundice on birth did not 

clear up after several weeks, and she was flown to a military hospital in 
Germany where the possibility of biliary atresia was diagnosed. Her military 

physicians were not optimistic regarding her survival^ and indicated she 
would probably die within several months without major surgery. 

Adriane was then transferred to Walter Reed Army Medical Center, where 

additional tests confirmed the diagnosis of biliary atresia. Since the Army 

medical system could not perform corrective srugery, she was transferred to 
Children's Hospital., National Medical Center in Washington, DC, in February 
1981. 

There it was decided a KASAI procedure would be necessary in order to 
find bile ducts large enough to permit bile flow from the liver. 

With only a 50% chance of success, the operation was performed by Dr. 
Kathryn Anderson. After some complications., she responded to the surgery and 
was released in March 1981. 

Then stationed in Alabama, her condition began to again deteriorate in 
April. As a result, she was admitted to Vanderbelt University Medical Center 
in May. Dr. Wallace Neblett revised the original KASAI procedure, but the 
advancing cirrhosis she developed made the operation difficult. Her prognosis 
upon release was poor - it was felt her liver would fail, and she would die 
within a year. 

She suffered increased bleeding from a portoenterostomy in June, and was 

a galn readmitted to Vanderbelt for additional surgery. 



12 



After she was released., she was followed by numerous military and civilian 
physicians in an attempt to stabilize or delay the advancing deterroration of 

her liver. 

In August^ 1982, after examination by Dr. John Andersen of the University 
of Texas Health Science Center at Dallas, the possibility of a liver transplant 
was discussed as the only way to save her life. 

We then travelled to the University of Tennessee Center for the Health 
Sciences in Memphis, one of the few centers doing transplants. Dr. James W. 
Williams confirmed her prognosis, and suggested Adriane would be an ideal 
candidate for a transplant. After a long period of hopelessness., watching 
her slowly die., a transplant gave us our first hope for her continued survival. 

Little did we know that her continually deteriorating medical condition and 
the difficulty in finding a suitable organ for transplantation were not the 
only obstacles to overcome in saving her life. 

As an active-duty member of the armed forces., CHAMPUS is responsible for 

providing medical care for my family if the normal military medical system 
cannot provide certain care. 

After allowing coverage for three major operations, we were surprised to 
learn CHAMPUS would only pay for her to die in a hospital and not for the 

liver transplant which would save her life. If at any point a transplant was 

necessary, I was on my own for the bills. 

Since $65,000 is the cost of admittance for the hospital doing the 
transplant, my only available means of getting the necessary funds to save my 



13 



daughter's life would be public funding raising or Medicaid, Further 
investigation revealed three reasons why my daughter's medical condition 
was disallowed by CHAMPUS. 

The first is since there are a limited number of centers who are actively 
doing the procedure, liver transplantation cannot be readily replicated nor be 
provided with a predicted level of success at a significant number of facilities, 
it does not meet the generally accepted standards of usual professional medical 
practice in the general medical community. 

The question as to whether this procedure is routine is not for me to 
answer., but I assume the testimony the physicians from the various centers have 

given adequately demonstrate that liver transplantation is an accepted standard 

of usual medical practice for treatment of severe liver dysfunctions. 

The second consideration is that "other federally funded health programs, 
as well as other third-party payors also consider the procedure to be inves- 
tigational." 

This is based upon an outdated NIH survey conducted in October of 1980 
which states the liver transplant success rate is approximately 38%. This 
survey was prior to the use of Cyclosporin A, and only mentions Cyclosporin A 
as being used in limited human trials. The success rate is obviously higher. 
As far as other federally funded health programs., I have received limited 
Massachusetts Medicaid coverage because of Senator Kennedy's efforts, and it 
is my understanding numerous states like New York and Pennsylvania consider 
liver transplants therapeutic. From my own experience, the University of 
Tennessee has informed me the only major insurance carrier who has not provided 



14 



coverage at that hospital is CHAMPUS. 

The final consideration is "the high cost of the procedure^ typically 
$50,000 - 60^000^ versus the expected long-range benefit to be derived." 

I personally find this argument repugnant since it defacto has set a dollar- 
value to my daughter's life. It would appear CHAMPUS is all too willing to 
pay for her to die, at a greater cost, than for her to live. The expected 
long-range benefit is her life. If economics is the consideration then the 
transplant is "cost-effective," a position reinforced by the Surgeon General 
of the US. 

Why is the reimbursement issue important - without the funds to gain 
admittance, improved procedures for liver procurement are unnecessary. 

In conclusion, Adriane is still suffering from the debilitating effects 
of her biliary atresia, and ultimately she will succumb to liver failure, 
probably within 18 months. 

She does have hope for continued survival with a good quality of life if 
she receives a successful liver transplant. This of course is dependent on 
our ability to afford the operation. 

Your recommendations that liver transplantation is not investigational, 

with improved methods of organ procurement., and the legislation currently in 
Congress which allows wide-spread acceptance of the procedure, can save 

numerous lives from liver disease - possibly Adrianes'. 

That concludes my oral testimony. 



15 



BIOGRAPHICAL SKETCH 



JOHN M. BRODERICK 



CAPTAIN, UNITED STATES ARMY 



John M. Broderick, III, was born in Ft Dix, NJ, on 30 May 1956. He 
graduated from High School in Bellingham, Massachusetts. He earned a 
Bachelor of Arts Degree from Providence College in 1978. 

He began his active duty career in June 1978 as a Second Lieutenant in 
the Ordnance Corps, and graduated from the Ordnance Officer's Basic 
Course (phase II - nuclear) as Distinguished Graduate. 

From February 1979 to April 1982, he served in the 558th USAAG, Greece. 
In April 1982, he returned to Redstone Arsenal, Alabama, and was assigned 
to the 515th Ordnance Co. 

In 1983, he graduated as the Honor Graduate, Ordnance Officer Advanced 
Course. He is presently assigned to the Louisiana Army Ammunition Plant, 
Shreveport, Louisiana. 

Personal Data 

Born: 30 May 1956 - Ft Dix, NJ 

SSN: 014-48-5891 

Parents: John M. and Sara P. Broderick, Jr. 

Wife: Janet M. Broderick 

Children: Adriane Marie Broderick 

Home Address 

19 Colin P. Kelly Drive 
Minden, Louisiana 71055 

Phone: (318)459-5309 



16 

Mr. Gore. Our next witness is Dr. James Williams, associate pro- 
fessor of surgery at the University of Tennessee College of Medi- 
cine. Dr. Williams, we are honored to have you with us today. 
Please proceed with your testimony. 

Dr. James Williams. Mr. Chairman and members, thank you for 
allowing us the opportunity to come to Washington and speak with 
you on this issue we consider to be very important to the health of 
a growing number of Americans. 

I want to personally express my thanks to Mrs. Hall for her her- 
culean efforts to come here, and her almost unbelievable compo- 
sure on her day of days, regardless of the outcome. 

The development of liver transplantation at the University of 
Tennessee Center for the Health Sciences is outlined in my written 
testimony. 

In summary, we initiated our liver transplant program in May 
1982, a project based on extensive laboratory and clinical prepara- 
tion. Since that time, a little less than a year now, we have per- 
formed a total of seven transplants, three of the patients have been 
discharged home, and two other patients, recently done, are await- 
ing discharge. 

This very gratifying start illustrates the concept that liver trans- 
plantation can be performed successfully by more than a few select 
centers. Several other centers are now organizing liver transplant 
programs. Given adequate preparation, these programs will prove 
similary successful and dispell the myth that liver transplantation 
is merely a clinical experiment. 

As a new liver transplant program, we face two major problems. 
The first problem, encountered by approximately half the patients 
referred to us, is the lack of financial support for the procedure. 
All Federal agencies, including CHAMPUS and medicare, and 
many private insurance carriers refuse to cover the procedure be- 
cause of its experimental status. 

The second problem we have encountered is the frequent difficul- 
ty in finding a liver donor, particularly for a small child. Since the 
child with end-stage liver disease has a relatively short period of 
time to live, and since the donated liver is viable for a only a short 
time once it is removed from the cadaveric donor, and since the 
number of pediatric donors itself is small, the urgency of the need 
for a donor can literally reach life and death magnitude. The wit- 
nesses here today, Brandon and Mrs. Hall, as well as Adriane 
Broderick, illustrate these two problems as graphically as they 
could possibly be illustrated. 

Mrs. Hall, confronted with a fatal illness in her child, has been 
able to raise the necessary money and assure her son's admission 
to a transplant center. Several other patients we have seen, howev- 
er, in this same situation, have not been so successful and have 
since succumbed. 

What can be done at a national level to assist in solving these 
problems? I don't have any magic solutions, but I have a few sug- 
gestions for your consideration. One, in the area of donor availabil- 
ity, public awareness and public understanding of the problems in- 
volved is important— is probably the most important thing we can 
pursue at this stage. The general public, I don't believe, realizes 
the seriousness of the problem, nor the precious quality of this re- 



17 

source, donated solid organs. Organ donation always comes at a 
tragic time. It is not a time when the family can think rationally. 
These decisions have to be made at a prior time. This is in the 
realm of public education, public relations, ways of educating the 
public. 

A second route to take is in hospital involvement. There are a 
number of hospitals in this country in which organ donation occurs 
rarely, is rarely considered. In smaller hospitals, the knowledge for 
the need is not disseminated. I think we have to need to have a 
uniform policy in our hospitals about the approach to organ dona- 
tion. If the intensive care unit nurses or someone designated within 
those units were given the opportunity or the job or the responsi- 
bility for doing this to everyone, presenting the opportunity for 
organ donation for every family with a relative or member of their 
family dying, I think we would see increased availability of organs. 
This would ritualize the process, defuse some of the emotionalism, 
and make it a regular part of the care of this type of person. 

In the area of funding, I would encourage us to make some steps 
toward assuring uniformity in our hospital insurance carriers. A 
number of carriers have, in my opinion, hidden behind the term 
"experimental." This term is too vague in a time of inovation, 
when new things are happening all of the time. If we excluded pay- 
ment on the basis of experimental or newness, we would never do 
anything new, we would never make any advances. So that needs 
to be defined. 

For those who do not have insurance — which probably represents 
a large segment of children, because children happen to be the de- 
pendents of young working people, many time changing jobs and 
changing insurance companies, and a new insurance company may 
not pick up the tab for a pre-existing illness — we still have a 
number of people who don't have coverage at all. We could consid- 
er doing these transplants with funding through the clinical re- 
search center system. 

I don't know how much money that would take, but it would ac- 
complish three things. One, it would take care of the patients who 
need a liver transplant in this country. Second, it would improve 
the research and developmental support that we all agree is 
needed. Third, it would do this without creating any new laws, 
without creating any new bureaucracy, and without committing 
funds for an indefinite period of time. This would be research-relat- 
ed money. 

I appreciate the opportunity to come to Washington to testify, 
and I will be happy to answer questions should they arise. Thank 
you. 

Mr. Gore. Thank you very much, Dr. Williams. 

We will hold questions until Mr. Hall has had an opportunity to 
testify. 

[The prepared statement of Dr. James Williams follows:] 



18 



LIVER TRANSPLANT PROGRAM AT 

THE UNIVERSITY OF TENNESSEE 

CENTER FOR THE HEALTH SCIENCES 

The liver transplant program at the University of Tennessee began in 
May of 1982, becoming the third active program in this country and the first 
program to become organized in the Cyclosporine era. This program has evolved 
in a major university setting and draws extensively from the expertise of 
physicians and technicians in a wide variety of medical and scientific 
disciplines. This broad background of support is extremely valuable, since 
the problems encountered with patients in end-stage liver disease can be 
both numerous and complex. Having accounted for this broad support, I would 
like to concentrate this testimony on the development of the surgical aspects 
of this program, and the problems encountered by the family of a small child 
needing a liver transplant. 

A kidney transplant program at the University of Tennessee began in 1970 
and has been responsible for the development of an active organ retrieval 
effort, as well as the performance of approximately 350 renal transplants. 
This effort, based on the treatment and follow-up of patients receiving kidney 
transplants, has provided the liver program with considerable experience in 
transplantation biology and the management of immunosuppressed patients. 

The author's interest in transplantation began in 1978, when he spent 
six weeks at the University 'of Colorado observing the program under the 
direction of Thomas Starzl, M. D. Fortified by the belief that a similar program 
could be initiated elsewhere, we began preparations for a liver program at the 
University of South Florida in Tampa. When it became apparent that this could 
not be accomplished in that institution, the University of Tennessee accepted 
our offer to start a program in Memphis. 



19 



Liver Transplant Program April 13, 1983 

Congressional Testimony Page Two 



Preparation for this program included recruitment of two skillful 
surgeons experienced in kidney transplantation and general surgery. Over a 
two year period, these surgeons and I carefully dissected the liver in 
several cadavers in order to become familiar with the frequent variations in 
liver anatomy and the technical aspects of multi organ retrieval. During 
and preceding this two year period, we conducted a series of canine liver 
transplant experiments, investigating the use of Cyclosporine. In addition 
to the experimental data generated, these experiments provided valuable 
technical experience in liver preservation and in the actual performance 
of the transplant operation, which has been heavily drawn upon in the 
subsequent clinical series. 

Based on this laboratory and clinical preparation we began our 
program and performed the first liver transplant in May of 1982, using 
Cyclosporine as the mainstay of immunosuppression. In the nine months 
since that time we have transplanted seven patients, three of whom have 
been discharged home and two are awaiting discharge. We currently have two 
patients with end-stage liver disease awaiting a suitable donor. 

The results of our program support the concept that hepatic transplanta- 
tion is a procedure of genuine therapeutic benefit. The patients selected for 
transplantation at our institution have had end-stage liver disease and were 
expected to live only a few weeks or months . The experience from our 
institution indicates that, with careful preparation, a new program can 
provide liver transplantation therapy in a safe and efficacious manner. 
Enough details of the surgery and care of the patients are known so that 
duplication of these results should be expected at other similar institutions. 



20 



Liver Transplant Program April 13, 1983 

Congressional Testimony Page Three 



It is, therefore, our opinion that liver transplantation should no longer 
be considered experimental. This designation, used by several Federal and 
private health care providers, denies transplantation to approximately one- 
half of the patients referred to us with end-stage liver disease. 

The child appearing before your committee, Brandon Hall, is a one year 
old boy with a disease called biliary atresia. This is a condition, present 
from infancy, in which the bile ducts normally connecting the liver to the 
intestine are absent. Since bile is denied entry into the intestine, the 
child becomes jaundiced and the liver experiences progressive scarring and 
progressive loss of function. Symptoms of this disease include itching, 
increased susceptibility to infection, fluid retention, vitamin malabsorption, 
bleeding problems, growth failure and others. This condition occurs approxi- 
mately in one in every 8,000 to 12,000 births and proves fatal in the majority 
of affected children before the age of 3 years. Therapy for this condition 
includes both surgical attempt at bile drainage (helpful in a small number of 
children) and the treatment of symptoms produced by the obstructed bile flow. 
Since the liver is progressively destroyed by this condition, the only hope 
for extended life is a successful liver transplant. 

Liver transplantation is a complicated, lengthy and tedious procedure. 
The current evidence suggests that it can be successful in up to 60% to 70% 
of the patients. 

Liver transplantation in children is complicated by two features. The 
first feature is the relative scarcity of suitable donors for children. The 
second feature is the disproportionately high incidence of clotting of the 
artery supplying small livers in these children. This is a fatal complication 
unless another liver can be quickly found. 



21 



Liver Transplant Program April 13, 1983 

Congressional Testimony Page Four 



Last year Brandon's mother, Mrs. Billie Hall, was told that her six 
month old son could not survive without a liver transplant. In addition to 
the uncertainties regarding the future of her child, she was also told that 
financing was a major problem. Since she had no insurance and the medical 
care she had been receiving was afforded by Medicaid, she was told that her 
child could not have a transplant unless she could raise the money herself. 
In an all out appeal, Mrs. Hall was able to raise approximately $75,000.00, 
and thereby, provide her son with access to this therapy. When we saw the 
child for the first time, he weighed approximately eleven pounds and appeared 
to be in poor condition. Through the therapy initiated by Dr. Peter Whitington, 
Pediatric Gastroenterologist at LeBonheur Children's Hospital at the University 
of Tennessee Center for the Health Sciences, Brandon has been able to grow and 
gain weight. However, in the past few weeks his growth has stopped and 
complications related to a failing liver have appeared. He is becoming 
increasingly jaundiced, lethargic, and has constant fever of 101° to 102°. 

Brandon Hall is now on the urgent list awaiting a new liver. Providing 
a liver can be found, we believe his chances for long-term, indefinite survival 
are good. Without the transplant he will live only a few weeks. 

The future of liver transplantation will depend upon two broad areas of 
advance. The first area will be improvements in the control of rejection 
and improvements in the technical aspects of performing the surgery. This 
will require research support. The second area of advance will come from public 
awareness of the precious resource organ donation represents. Kidney and 
cornea transplantation has been performed for over two decades and has afforded 
thousands of people a richer and fuller life than otherwise possible. 



22 



Liver Transplant Program April 13, 19R3 

Congressional Testimony Page Five 



In many cases successful kidney transplants have undoubtedly improved life 
expectancy as well, but an alternate form of life sustaining therapy (dialysis) 
is available to patients with kidney failure. On the other hand, there is 
no meaningful therapy short of transplantation for patients with end-stage 
liver failure. Since the patient with end-stage liver disease has a 
relatively short period of time to live, and since the donated liver is 
viable for only a short time, once it is removed from a cadaveric donor, 
new urgency is being progressively placed upon organ procurement. Based 
on vital statistics defining both the incidence of death from liver disease 
and the number of potential organ donors, it appears that the supply of 
needed livers can be readily met. Meeting this- need, however, will come 
through public education and efforts such as this committee is promoting. 
Thank you for the opportunity of appearing before your committee. 

Yours truly, 




James W. Williams, M. D. 
Associate Professor of Surgery 

JWW:lc 



23 

Mr. Gore. Mr. Gary Hall is the transplant coordinator with the 
University of Tennessee College of Medicine in Memphis. Welcome, 
Mr. Hall. 

Mr. Gary Hall. Thank you, Congressman Gore, for the opportu- 
nity to appear this morning. 

Mr. Gore. Congratulations on your success this morning, Mr. 
Hall. 

Mr. Gary Hall. Thank you. That really is the success of the co- 
operative efforts that go on at all times among transplant coordina- 
tors in this country. It is not my success, it is our success. 

I have been requested to relate the activities or our organ pro- 
curement program in locating suitable organs for transplantation. 
My specific remarks will outline my activities related to finding a 
suitable liver for a small pediatric recipient, such as Brandon Hall, 
and the general approach to organ procurement at the University 
of Tennessee. 

Rarely are organ donors "found" by organ procurement coordina- 
tors; rather, organ donors are brought to the attention of coordina- 
tors as a result of a referral by health professionals not normally 
involved in organ procurement. 

Locating a suitable liver for a small pediatric recipient — or really 
any recipient — involves a two-pronged effort: first of all, a local 
effort, an ongoing systems approach that will be described later; 
and two, a nationwide effort. This nationwide effort involves listing 
the patient, along with acceptable donor parameters, on a national 
telephone system called the North American Transplant Coordina- 
tors Organization 24-Alert phone system; 24-Alert is an acronym 
for the phone number of this system, and is accessible from any 
telephone in the world. Mr. Don Denny, director of organ procure- 
ment at the University of Pittsburgh which administers this 
system, will comment later during these hearings relative to the 
mechanics of that system. 

In particularly urgent cases, such as the one involving Brandon 
Hall, various organ donor programs are directly contacted to make 
them aware of our need and requested not to reject infants as 
organ donors in contrast to the usual policy — infant kidneys are 
rarely needed for transplants. In these situations, our program ac- 
cepts full fiscal responsibility for the organ retrieval procedure 
where there is considerable doubt as the transplantability of the 
donor's kidneys. To date, we have been successful in procuring a 
suitable organ for every eligible patient awaiting liver transplanta- 
tion at our center. 

Our local organ procurement program, similar to organ procure- 
ment programs in other areas, has been marginally successful in 
retrieving an adequate number of organs for transplant. 

The various attachments to this testimony represent our efforts 
to develop an understanding of the inhibitions physicians and 
nurses in our community have toward participating in organ pro- 
curements. For a very long time now, organ procurement has been 
struggling to be universally recognized in our medical community 
as a valid and legitimate endeavor. Often those in authority in the 
hospitals in our area, upon which we rely for eligible organ donor 
referrals, either acquiesce or are apathetic to our requests to be 



24 

permitted to educate and inform nurses and physicians working in 
hopital areas where organ donors are most likely to be found. 

In contradistinction to the lack of uniform affirmative support 
for organ donation on the part of hospitals in our area, we have 
the definite impression that a majority of physicians and critical 
care unit nurses favor cadaveric organ donation. This impression is 
confirmed by positive responses to the survey questions concerning 
physicians' and nurses' attitudes toward personal organ donation- 
attachments one and four. 

Despite these favorable attitudes, it is clear that a majority of 
donors are not identified and referred to the transplant program. 
Furthermore, it is the perception of most critical care nurses that a 
majority of eligible donors under their care are not identified nor 
are their families advised of their right to exercise the organ donor 
option — attachments two and four. 

In attachment four can be found data suggesting that consider- 
able uncertainty exists on the part of critical care nurses as to 
their hospital's position on organ donation. This fact further sug- 
gests possible contributing causes of the nurses' uncertainty about 
the identification of eligible organ donors. 

Due to the lack of a uniform systems approach, organ procure- 
ment coordinators spend most of their time selling through in-serv- 
ice seminars and unscheduled visits to critical care units to ac- 
quaint critical care nurses with organ donation procedures. These 
sessions generally include an emotional appeal to the nurses to ap- 
proach families of eligible organ donors or, at the very least, to con- 
tact the organ procurement coordinator and permit them to discuss 
donation with the potential donor's family. 

The foregoing is not intended as an indictment of hospitals, phy- 
sicians or nurses, nor is it intended to characterize them as apa- 
thetic toward the needs of patients awaiting transplantation. These 
institutions and professionals have some real and legitimate con- 
cerns about their participation in facilitating organ donation. 
These concerns may be summarized as follows: 

One, the majority of organ donations occur in acute care hospi- 
tals not associated with organ transplant programs. Consequently, 
the focus of attention of these hospitals and staff is on aspects of 
patient care not related to transplantation. Organ donation does 
not directly benefit their patient population. 

Second, there exists a general belief on the part of the physicians 
and nurses that organ donation does not enjoy widespread public 
support. That this notion has merit was confirmed in a public opin- 
ion survey conducted by the Gallup Organization earlier this year. 
This survey performed, for the National Kidney Foundation, found 
that only 40 percent of those polled— 44 percent of white partici- 
pants, and only 20 percent of black participants— indicated they 
were either very or somewhat likely to want their own kidneys do- 
nated after their death. Our experience in Memphis, where the 
proportion of blacks in the population approaches 50 percent, con- 
firms the findings of the Gallup survey. Approximately 20 percent 
of black families approached about organ donation ultimately con- 
sent to it. This circumstance serves to discourage physicians and 
nurses treating a black patient who dies, and is otherwise suitable 
for organ donation, from approaching that patient's family. 



25 

Finally, a continued major concern is the issue of public accept- 
ance of brain death as the death of the person. Most physicians and 
a majority of legislators accept the idea that an individual who has 
suffered irreversible cessation of total brain function, regardless of 
the continuance of function of other organ systems, is legally dead. 
The level of certainty among critical care nurses is somewhat less 
than that of physicians. It is not surprising, therefore, that a sub- 
stantial proportion of families have difficulty accepting the expla- 
nation that one is dead when they feel a pulse and see them 
breathing, albeit that these processes are mechanically maintained. 
It requires a concerned, compassionate and committed physician 
and/or nurse to spend sufficient time with the family to help them 
understand that their relative is truly dead. Family acceptance of 
brain death of the individual is absolutely essential before a discus- 
sion of organ donation can ensue and be expected to result in con- 
sent for organ donation. 

In conclusion, two things will have to occur before an adequate 
number of organs for transplant will be available, in my opinion. 
One, the adoption of uniform policy and procedures by all acute 
care hospitals specifically delineating organ donor criteria and ap- 
propriate procedures to ensure that the families of all eligible 
organ donors are afforded the opportunity to donate. It is impera- 
tive that all physicians and nurses staffing the emergency rooms 
and intensive care units in these institutions be thoroughly versed 
in such policies and procedures. 

Second, adequate funding must be provided for an ongoing, con- 
sistent and professionally done public education program. This pro- 
gram's goal should be to help the public understand that brain 
death is death and, further, to persuade and motivate a majority of 
Americans to become organ donors. 

Thank you for the opportunity to appear here today. 

Mr. Gore. Thank you, Mr. Hall. 

[The prepared statement of Mr. Gary Hall follows:] 



26 



ORGAN PROCUREMENT PROGRAM AT 

THE UNIVERSITY OF TENNESSEE 

CONGRESSIONAL TESTIMONY 

I have been requested to related the activities of our Organ Procurement 
Program in locating suitable organs for transplantation. My specific remarks 
will outline my activities related to finding a suitable liver for a small 
pediatric recipient, such as Brandon Hall, and the general approach to Organ 
Procurement at The University of Tennessee. 

• Rarely are organ donors "found" by organ procurement coordinators; rather, 
organ donors are brought to the attention of coordinators as a result of a 
referral by health professionals not normally involved in organ procurement. 

Locating a suitable liver for a small pediatric recipient involves a two 
pronged effort: (1) a local effort - an on-going systems approach that will be 
described later; and (2) a nationwide effort. This involves listing the 
patient, along with acceptable donor parameters, on a national telephone system 
called, "The North American Transplant Coordinators Organization 24-Alert" phone 
system. 24-Alert, an acronym for the telephone number of this service, is 
accessible from any telephone in North America. Mr. Don Denny, Director of 
Organ Procurement at The University of Pittsburg, administers the system, and 
will comment during these hearings relative to the mechanics of this system. 

In particularly urgent cases, such as the one involving Brandon Hall. 
Various organ donor programs are directly contacted to make them aware of our 
need and requested not to reject infants as organ donors in contrast to the 
usual policy (infant kidneys are rarely needed for transplants). In these 
situations our program accepts full fiscal responsibility for the organ 
retrieval procedure where there is considerable doubt as to the transplan- 
tability of the donor's kidneys. To date, we have been successful rn procuring a 
suitable organ for every eligible patient awaiting liver transplantation at our 
center. 

Our local organ procurement program, similar to organ procurement programs 
1n other areas, has been marginally successful in retrieving an adequate number 
of organs for transplant. 

The various attachments to his testimony represent our efforts to develop 
an understanding of the inhibitions physicians and nurses 1n our community have 
toward participating 1n organ procurement. For a very long time now, organ pro- 
curement has been struggling to be universlally recognized in our medical com- 
munity as a valid and legitimate endeavor. Often those 1n authority 1n the 
hospitals 1n our area, upon which we rely for eligible organ donors, either 
acquiesce or are apathetic to our requests to be permitted to educate and 
Inform nurses and physicians working 1n hospital areas where organ donors are 
most likely to be found. 

In contradistinction to the lack of uniform affirmative support for organ 
donation on the part of hospitals within our area, we have the definite 
Impression that a majority of physicians and critical care nurses favor cada- 
veric organ donation. This Impression 1s confirmed by positive responses to 
survey questions concerning physicians and nurses' attitudes toward personal 
organ donation (Attachments One and Four) 



27 



Despite these favorable attitudes, it is clear that a majority of donors 
are not identified and referred to the Transplant Program (Attachment Three). 
Furthermore,, it is the perception of most critical care nurses that a majority of 
eligible donors under their care are not identified nor are their families 
advised of their right to exercise the organ donor option (attachments Two and 
Four). 

In Attachment Four can be found data suggesting that considerable uncer- 
tanity exists on the part of critical care nurses as to their hospital's position 
on organ donation. This fact further suggests possible contributing causes of 
the' nurses' uncertainty about the identification of eligible organ donors 
(Attachment Four). 

Due to the lack of a uniform systems approach, organ procurement coor- 
dinators spend most of their time selling, through, in-service seminars and 
unscheduled visits to critical care units to acquaint critical care nurses with 
organ donation procedures. These sessions, generally include an emotional 
appeal to the nurses to approach families of eligible organ donors or, at the 
very least, to contact the organ procurement coordinator and permit them 
to discuss the donation with the potential donor's family. 

The foregoing is not intended as an indictment of hospitals, physicians or 
nurses, nor is it intended to characterize them as apathetic toward the needs of 
patients awaiting transplantation. These institutions and professionals have 
some real and legitimate concerns about their participation in facilitating 
organ donation. These concerns, may be summarized as follows: 

I. The majority of organ donations occur in acute care hospitals not 
associated with organ transplant programs. Consequently, the 
focus of attention of these hospitals and staff is on aspects of 
patient care not related to transplantation. Organ donation does not 
directly benefit their patient population. 

II. There exists a general belief on the part of physicians and nurses 
that organ donation does not enjoy widespread public support. That 
this notion has merit was confirmed in a public opinion survey con- 
ducted by the Gallup Organization earlier this year. This survey, 
performed for The National Kidney Foundation, found that only 40% of 
those polled (44% of white participants and 20% of black participants) 
indicated they were either very or somewhat likely to want their own 
kidneys donated after their death. Our experience in Memphis, where 
the proportion of blacks in the population approaches 50%, confirms 
the findings of the Gallup Survey - approximately 20% of black fami- 
lies approached about organ donation ultimately consent. This cir- 
cumstance serves to discourage physicians and nurses treating a black 
patient who dies, and is suitable for organ donation, from approaching 
the patient's family. 

III. A continued major concern is the issue of public acceptance of brain 
death as the death of the person. Most physicians and a majority of 
legislators accept the idea that an Individual who has suffered 
irreversible cessation of total brain function, regardless of the con- 
tinuance of function of other organ systems is legally dead. The 



28 



level of certainty among critical care nurses is somewhat less that 
that of physicians (Attachments One and Four). It is not surprising 
therefore, that a substantial proportion of families have difficulty 
accepting the explanation that one is dead when they feel a pulse and 
see them breathing, albeit that these processes are mechanically 
maintained. It requires a concerned, compassionate and committed phy- 
sician and/or nurse to spend sufficient time with the family to help 
them understand that their relative is truly dead. Family acceptance 
of brain death as death of the individual is absolutely essential 
before a discussion of organ donation can ensue and be expected to 
result 1n consent for organ donation. 

In conclusion, two things will have to occur before an adequate number of 
organs for transplant will be available: 

I. The adoption of uniform Policies and Procedures by all acute care 
hospitals specifically delineating organ donor criteria and 
appropriate procedures to ensure that the families of all eligible 
organ donors are afforded the opportunity to donate. It is imperative 
that all physicians and nurses staffing the emergency rooms and inten- 
sive care units in these institutions be thoroughly versed in such 
Policies and Procedures. 

II. Adequate funding must be provided for an on-going, consistent, pro- 
fessional done Public Education Program. This program's goals should 
be to help the public understand that brain death is death and, 
further, to persuade and motivate a majority of Americans to become 
organ donors. 

Thank you for the opportunity of providing this testimony to your 
committee. 



Gary Hall 

Transplant Coordinator 



29 



ATTACHMENT NUMBER ONE 
PHYSICIAN SURVEY 



During the late autumn and early winter of 1979, the attached questionnaire 
pertaining to physician attitudes towards organ donation was mailed to approxi- 
mately 1,500 physicians in Memphis and Shelby County, Tennessee. The mailing 
list comprised those physicians who were active members of the Shelby County 
Medical Society and resided in Shelby County. This questionnaire was patterned 
after one utilized by the Nashville Transplant Program in 1972 (see attached 
reprint.) A total of 574 physicians responded to the questionnaire, approxima- 
tely 38%. 

DEMOGRAPHICS OF RESPONDENTS 





Age 




Age 


Number 


Percent 


29 or less 


135 


23.5 


30-34 


115 


20.0 


35-39 


68 


11.8 


40-44 


60 


10.5 


45-49 


40 


7.0 


50-54 


47 


8.2 


54-59 


48 


8.4 


60-64 


30 


5.2 


65 or over 


29 


5.1 



Sex 

Sex Number 

Male 507 
Female 51 
Not Answered 16 



Race 



Race 



Number 



Percent 

88.3 
8.9 

2.8 



Percent 



Caucasian 481 


83.8 


Negro 9 


1.6 


Oriental 11 


1.9 


Not Answered 73 


12.7 



Religion 
Religion Number Percent 



Protestant 


387 


67.4 


Catholic 


71 


12.4 


Jewish 


59 


10.3 


Other 






Christian 


13 


2.3 


Other 






Asian Sects 


11 


1.9 


None 


22 


3.8 


Not answered 


11 


1.9 



Speciality 
Speciality Number Percent 



Surgical 


126 


22.0 


Non-Surgical 


432 


75.3 


Not answered 


16 


2.8 




Present 


Position 


Position 


Number 


Percent 


House Staff 


159 


22.7 


Faculty 


101 


17.6 


Private 






Practice 


262 


45.6 


Other 


50 


8.7 


Not answered 


2 


0.3 



30 



The following tables indicate the responses tabulated to each of the six 
questions: 

8. CADAVERIC RENAL TRANSPLANTATION IS : 

A. Effective 168(29.3%) 

B. Effective in selected cases 372 (64.8%) 

' C. Still experimental 16 ( 2.8%) 

D. Dangerous or useless 3 ( 0.5%) 

Not answered 15 ( 2.6%) 

There were no differences in responses by Demographics except for medical 
specialties in which 45.1% of those identifying themselves as surgeons marked the 
"A." response as opposed to only 24.8% of the non-surgeons and 31.2% of those 
not indicating their speciality. 

9. ATTITUDE TOWARD KIDNEY DONATION AFTER MY DEATH: 



A. Organ donor card signed 246 (42.9%) 

B. Willing, but card unsigned 211 (36.5%) 

C. Would not sign, but donation acceptable 

if family consents 80 (14.1%) 

D. Opposed to kidney donation after my 

death 27 ( 4.8%) 

Not answered 10 ( 1.8%) 

Considering the "A." and "B." answers as positive responses and the "C." 
and "D." as negative responses, there were no differences in positive vs. nega- 
tive responses by age, sex, race, religion, speciality or position. However, 
when isolating the "A." Responses according to the above demographics several 
significant differences emerge. In the 40-44 age group, 58.3% claimed to have 
signed their organ donor card. There were no significant differences by sex. 
Although the numbers for non-caucasians were small, only 15% of this group vs. 
42.9% of the Caucasians vs. 50.7% of those not indicating their race claimed to 
have signed a donor card. The only other significant difference found related 
to the religion of the respondent: 52.9% of Catholics vs. 30.5% of the Jewish 
physicians marked response 'A." 



31 



10. ATTITUDE TOWARD FAMILY KIDNEY DONATION AFTER THEIR DEATH : 

A. All of age have signed the organ 

donor card 109 (19.0%) 

B. Not signed, but I would encourage them 

to do so 251 (43.9%) 

C. I am neutral on the mater of their 

signing a card 192 (33.2%) 

D. Opposed to kidney donation after their 

death 11 ( 1.9%) 

Not answered 11 ( 1.9%) 

Regarding "A." and "B." as positive responses and "C." and "D." as negative 
responses, there were found to be no significant differences by age, sex or 
medical speciality of the respondent. Again, the responses among non-Caucasians 
were few (20), but only 35% of non-Caucasians vs 64.9% of Caucasians responded 
positively to question 10. Among religious denominations, 50.9% of Jewish phy- 
sicians and 54.5% of "Other" groups and "None" combined vs 68.6% of Catholic 
physicians and 65.6% of Protestant physicians responded positively. Seventy-one 
and four tenths percent of house staff vs. 57.0% of faculty and 59.7% of private 
practice physicians responded positively. 

11. ATTITUDE TOWARD PATIENTS UNDER MY CARE: 



A. Would encourage them to sign organ 

donor card 286 (49.7%) 

B. If moribund, would encourage family 

to consent to donation 165 (28.7%) 

C. If moribund, would advise family of 

right to donate, but not encourage 82 (14.5%) 

D. Would not discuss matter with 

family at all 25 ( 4.2%) 

Not answered 16 ( 2.8%) 



32 



There were no significant differences identified when analyzing the data by 
the various demographic stratifications. 

12. CONCERNING THE DIAGNOSIS OF BRAIN DEATH : 

A. Am familiar with and accept criteria 

of brain death 448 (78,1%) 

B. Mot familiar with criteria, but would 

accept specialist's diagnosis 10/ U8.t>%) 

C. Death not related to brain function, 

but rather to cessation of circulation ,,,,_» 

and respiration 7 ( 1 '"' 

0. No opinion _ 8 ( lA%) 

Not answered 4 ( °* n) 

No differences in responses were identified among the various demographic 
stratifications. 
13 . CONCERNING THE MEDICO-LEGAL ASPECTS OF ORGAN DONATION: 

A. State laws provide Medico-Legal 

protection for organ donation ±5» U'.»*i 

B. Not familiar with laws, but feel 

potential legal liability is minimal 321 (55./%) 

C. Medico-Legal liabilities are major 

obstacle to organ donation ^3 i s.otj 

D. No opinion 59 (10.2%) 

Not answered 3 ( °' 5%) 

Although there were no significant differences in the responses by 

groups combined. 

The above survey results should be interpreted with caution since the level 
of reI5on.es does not represent a majority of physicians within the area sur- 
vived However, the proportionate level of participation is within expected 
eve?; compared to othVsurveys with similar format and method of distribution. 



33 



UNIVERSITY OF TENNESSEE 
COLLEGE OF MEDICINE 



JAMES W PATE M D 

Professor ft Chairman 



LOUIS G BRITT. M D 

Professor a Deputy 



DEPARTMENT OF SURGERY 
95 I Court Avenue 
Memphis, Tennessee 38163 



* Uimflm ft 



\ tl .^ 



Dear Doctor: 

Your help in taking a few minutes to complete the enclosed questionnaire would be deeply 
appreciated. For your convenience, this form has been layed out to permit ease in return. Of course, 
return postage has been prepaid. 

This study is being conducted under the auspices of the University of Tennessee Renal 
Transplant Program for the purpose of developing a better understanding of the prevailing views and 
opinions of physicians in the Mid-South toward renal transplantation and organ donation. 

Please rest assured that individual responses will in no way be identified as to their source, 
thus insuring strict anonymity 

Thank you in advance for your time and cooperation. 

Sincerely yours, 



Louis G. Britt, M.D. 

Director, Renal Transplantation 



RENAL TRANSPLANT QUESTIONNAIRE 

General Information 10 

(Circle Appropriate Response in Questions 1 through 5) 



ATTITUDE TOWARD FAMILY KIDNEY DONATION 
AFTER THEIR DEATH (check one) 



1 YOUR AGE: < 30. 30-34; 35-39; 40-44; 45-49, 50-54; 
55-59; 60-64; 65+ 



SEX: 



Race: Caucasian 

Negro Oriental 



4. RELIGION: Catholic Jewish 
Other (please specify) 



Prostestant 



5 YEARS IN PRACTICE: < 2; 2-5; 6-10; 11-15; 16-20; 
21-25; 25+ 



MEDICAL OR SURGICAL SPECIALTY 
PRESENT POSITION (Check One) 

a. Private Practice 

b. House Staff 



c Full Time Medical School Faculty 
d. Other (please specify) 



Organ Donation Information 

8 CADAVERIC RENAL TRANSPLANTATION IS: (check one) 



a. Effective 

b Effective in selected cases . 

c. Still experimental 

d. Dangerous or useless 



9. ATTITUDE TOWARD KIDNEY DONATION AFTER MY DEATH: 

(check one) 

a. Organ donor card signed 

\ b. Willing, but card unsigned 



c. Would not sign, but donation acceptable if 

family consents 

d. Opposed to kidney donation after my death. 

[ 



12. 



13. 



a All of age have signed the organ 
donor card 

b. Not signed, but I would encourage them 

to do so 

c. I am neutral on the matter of their 

signing a card 

d. Opposed to kidney donation after their death 

ATTITUDE TOWARD PATIENTS UNDER MY CARE: (check one) 

a. Would encourage them to sign Organ 

donor card 

b. If moribund, would encourage family to consent 

to donation 

c If moribund, would advise family of right to donate, 

but not encourage 

d. Would not discuss matter with family at all 



CONCERNING THE DIAGNOSIS OF BRAIN DEATH (check one) 
a. Am familiar with and accept criteria of 

brain death 

b Not familiar with criteria, but would accept 

specialists diagnosis 

c. Death not related to brain function, but rather to 

cessation of circulation and respiration 

d. No opinion 

CONCERNING THE MEDICO-LEGAL ASPECTS OF ORGAN DONATION 
(check one) 

a. State laws provide medico-legal protection 

for organ donation 

b. Not familiar with laws, but feel potential legal 

liability is minimal 

c. Medico-legal liabilities are major obstacle to 

organ donation 

d. No opinion 



34 



Physicians' Attitudes Towai 
Donation 

HARRY S. AURAM. MO. ROGER VANDF.R /.\VAA(. 
H. KEITH JOHNSON. MD.t Nashville, Term 



This material may be protected 
bv Copyright Law (Title 17 U.S CM" 

d Organ 



l'lil). ;md 



Tur. %\ rrLV of cadaveric homografls for renal 
transplantation depends not only upon public 
attitude toward oigan donation but upon tlie 
physician who provides care for the dying. 
Although the former has received some atten- 
lion, 1 " 3 the physician's viewpoint has not. This 
study represents an initial attempt to explore 
iliis area. 

Method 
In Ociober 1972 we circulated by mail a 
questionnaire to 1,100 physicians in Nashville. 
Tfim. and surrounding Davidson County 
(Table 1). In a covering letter we assured strict 
anonymity and enclosed an addressed, stamped 
envelope. Aside from general information (age. 
sex. race, religion, present medical position, 
medical or surgical specialty, years in practice), 
we diiccted four questions (with five graded 
multiple choice answers for each) toward the 
physician's attitudes involving the effectiveness 
of cadaveric renal allogiafis, the donation of 
his own kidneys in the event of his death, his 
family's donation of their kidneys after death, 
and the manner in which he discussed organ 
donation with dying patients or their families. 
Finally we asked for other comments. 

Respondents 
A total ol 542 physicians responded to the 
questionnaire or 49.37, of the 1,100 question 
naires. A recent study' of factors which influ- 
ence physi<ians' response to mailed question- 
naires indicated response rates varying from 
34.23% to 57.07% according to the format 
(including both design and reproduction pro- 
cess) and postage (primarily first class com- 

iriom the Department ol ritchialry (Dr. Abram). the De- 
itariiticiil ol ll.oitatmica (Dr. Zwaag), and the Department ol 
Undone. Vanrlcrbilt Univcnity School ol Medicine. Naih- 
,ille. Teem J72J2. 

Reprint irqunn 10 Dr. Abraro II the above adore*!. 

l-ie'rnied at The American Society lor Artificial Internal 
Oi|ani. Clncajo. April 4. 1974. 



pared with bulk or third class). Within that 
siiuly the format and postage most similai 10 
those used in this report had a response rate of 
5-1.47% among a sample si*c of 3RD. Hence, a 
response rale of 4!l.3% should be considered 
within the expected range. 

Of the respondents. 93.97, were men, 5.57 
were women, and three or 0.07,, refused 10 
state their sex. Ninety-five and nine tenths 
percent of the respondents were while. Fne 
respondents refused to state their rate. As the 
icsponse rate was thus very low among the 
nonwhile physicians in Davidson County, ihis 
study provides no reliable information about 
the influence of race upon physicians' alti- 
tudes toward cadaver donation. Clearly the 
largest percentage (G7.27„) of the respondents 
were Protestant. A majority wcrcintci ns and 
residents as is evident from the large number 
(104) of individuals younger than 29. Half, or 
50.77,. of the respondents were engaged in 
nonsurgical specialties; 32.17 wcic engaged 
in specialties requiring some singled pro- 
cedures; and 17-2','n were engaged in other spe- 
cialties or failed io answer (Tables 2 1). 

Responses 
The multiple choice answers to cadi of the 
four basic questions described earlier were 
arrangetl in dccicasing order from a most 
favorable attitude to a least favorable attitude 
toward cadaveric renal donation. In those cases 
where the physician marked more than one 
answer to a specific question, the answer show- 
ing the most favoiable attitude was selected. 

For analytical purposes, those opinions ex- 
pressing belief that renal transplants aie effec- 
tive or moderately effective were giouped 
together; opinions that transplants would soon 
or hail potential to be effective were grouped; 
and negative opinions and refusals io answer 
were grouped. Most tespondents (85.8%) be- 



SOUTHIRN MEDICAL JOURNAL, APRIL 1975— Vol 68. No. 4 



443 



35 



PHYSICIANS' ATTITUDES TOWARD ORGAN DONATION— Abram et al 
TABLE 1 

IR\N5rLANT QUESTIONNAIRE 



Cfifal Information 

I. Your age 2. ki- 

V rate 4. id if 

3. Present position (check one): 
a. House staff 



t>. Fulltime medical school faculn 

c. Pi i vale praci.ee 

U. Other 



MciIh a I or surgical sr>cciali>- 
\ears in practice 



i'ni'c.itr Donation Infc matron 
ft. 1 consider tcn.il transplantation using cadaver sili.guln (duck one): 
a. An effective and pto\tn method or treatment 



b A moderate!) effective mrtln>d of ireatment in selected caves 

c. Still in the experimental stage but will toon become a pio\en method of iiejtmcnt 

d. An efcpeiinuntal pro* r dure with poteniial for becoming a prnvrn method of treatment but some years 
oil 



e. A dangerous or use lets procedure of no clinical value 

Concerning donating m> own ktdnos in th« event of death (check one): 
a. I have signed and earn the Uniform Anatomical Cifl Act Caid 



I Hould sign anJ cair> the Uniform Anatomical Gift Act Card if presi-nted to me— ■ 

1 vould hesitate but prub^blv sign such a card— 

I would not sign such a card but do not feel upset at the thought that rov famil> might donate mv 
kidnevi after mv death 



e. Under no circumstances w-tiauortrr would I want my kidne)* used as cadaver organs 
Concerning members of rm (ainiK donating their kidneys after death (check one): 

a. Those of age have all signed the Anatomical Cifl Act Caid 

b. I would encourage them lo sign stu h a card 

C. 1 would be neutral on the matter of their signing a card, believing such a decision is a personal 



I would discourage their signing a card but allow them to do wi if ibry pcrsisted- 
1 would not allow them to donate their kidneys under am » iicumsianccs 



Concerning patients who are under mv care (check one): 

a. I would actively discuss the Anatomical Gift Act with ihem while they are in good health and encourage 
them to donate their kidney* — 

b If they ate moribund I would discuss the matter of donation with the patient's family and encourage 
them to donate the kidneys after death 

c. If ihey are moribund I would discuss the matter with the lamilv and tell them the kid neys could ho- 
used without encouraging or discouraging them to make a decision one way or the other 

d I would not discuss the matter with the family at all 

e. I would forbid the family to allow donation even if thev Insisted to do »o — — 

Comments: , 



lieved that renal transplantation is an effective Only 7.4% of the respondents had made pro 
or moderately effective treatment (Table 5). vision for the donation of their organs (b> 
The opinions on effectiveness were similar signing the Uniform Anatomical Gift Act 
for all religions, for surgical vs nonsurgical card), although 54.1% or over half the respon- 
specialties, and for all present positions (ie, dents indicated willingness to do so. Responses 
house staff faculty, etc). Opinions on effective- indicating hesitance, refusal, dislike, or a re- 
ness did differ, however, according to age. Of fusal to answer the question were grouped for 
the physicians vounger than 40, 89.2% be- analytical purposes, all of these responses being 
lieved transplan'ts to be an effective or moder- interpreted as a negauve attitude toward per- 
ately effective treatment. The corresponding sonal donation of organs. The personal dona- 
percentage for physicians 40 or older was "on status of the respondents was approxi- 
82.2% The difference in these two percentages mately the same for all religions, for surgical 
is statistically significant (p < .05). vs nonsurgical specialties, and for age (ie. 

444 SOUTHERN MEDICAL JOURNAL, APRIL 1975— Vol 68, No. 4 



36 



PHYSICIANS' ATTITUDES TOWARD ORGAN DONATION-Ab-im e 



I il 



PHYSICIANS' ATTITUDES TOWARD ORGAN DONATION— Abtjm ct il 



TABLE 2 
ktur.ioM or RESPONDENTS 



Religion 
Protestant 
Catholic 
Je«*ith 
Other . 
"Christian" 

Afnosiic 
Albeit! 

, None 

Noi aniwered 



Sumbet 

JM 
47 
40 
10 
16 







TABLE 4 








PRESENT POSH ION 




fr'frntagf 


roution 


Sumter 


Trf«: 


o: 2 


Home ii iff 


III 


m 


6 7 


Faculty 


1ST 


iSS 


7 4 


Practice 


C 1 1 


389 


16 


Oilirt 


41 


M 


30 


Nn| jn-uned 


1 


•k 



those younger than 40 as compared to those 
older). The proportion who were already or 
were willing to be donors did vary significantly 
(p =< .02) according to the present position of 
the respondent. House staff and faculty had 
the largest proportions of positive responses 
(70.9% and 63.5% respectively). Physicians in 
private practice had the lowest proportion 
(54.5%) who were already or were willing to be 
donors. Respondents in positions other than- 
house staff, faculty, or private practice respond- 
ed positively 58.17 of the time (Table 6). 

Sixty-one and six tenths percent of the re- 
spondents expressed a neutral attitude about 
members of their families being potential 
donors. Only ten respondents said they would 
discourage or forbid members of their families 
from being potential donors. Responses con- 
cerning family members did not differ signifi- 
cantly with regard to the religion, specialty, 
present position, or age characteristics of the 
respondents (Table 7). 

Those physicians who gave no answer to the 
question concerning discussion of the Ana- 
tomical Gift Act with patients or their families 
were excluded from the analysis since their 

TABLE 3 

ACE OF RESPONDENTS 



29 or younger 
JO M 
JS 39 
40 44 
45 49 
50 54 
55 59 
60 64 
65 69 
70 74 
75 + 

Not aniwered 



104 

90 

92 

65 

. 57 

41 

SS 

25 

9 

I 

6 



192 

16.6 

17.0 

12.0 

10 5 

89 

65 

4 6 

1.7 

15 

I.I 

0.6 



number included many physicians who had, 
little direct contact with patients. The propor- 
tion of respondents (excluding those who did 
not answer the question) who claim to dit-cuSS 
the Gift Act with all (heir patients is 28.6/? 
This proportion did differ significantly with 
respect to age (p<.05), but not with respect to 
present position, specialty, or religion. Fewer 
respondents younger than 40 discussed the Gift 
Act with their patients than older respondents 
the percentages being 22.7% and 36.1«J re- 
spectively (Table 8). 

Discussion 
The above findings point to some pielinu- 
nary but noteworthy trends. The number of 
physicians who have actually signed 'doiwr 
cards is surprisingly small (7.4%), even though 
a majority (54.1%) claim a willingness toAifn 
a card if presented to them. Likewise, few phy- 
sicians have family members who have signed 
the Gift Act card (4.1%); another 31.7f, state 
they would encourage ihcir family to do so 
This finding suggests that accessibility of don- 
or cards and increased public information nuy 
improve the proportion of physicians and their 
families who sign them. Several physician- 
commented on the lack of information in 
this area. As one stated, "The Anatomical 
Gift Act card is a well kept secret from 
the public and the medical profession at 
large." After the completion of this study, the 
State of Tennessee placed the statement. 
"Organ Donor, Yes. . . No " on its driver > 

TABLE 5 

OPINIONS ON EFFECTIVENESS 



Opinion 

Effective 

Moderately 

Effective 
Soon 
Potential 
Uaelea 

Kot xniKcred 



A urn 6c 
204 
261 



si 
S4 

I 



S.T 

#J 

p; 



SOUTHERN MEDICAL JOURNAL, APRIL 1975— Vol 68, No. 4 



445 



37 



fHYSICIANS' ATTITUDES TOWARD ORGAN DONATION-Abram ct al 



TAILE 6 

PLRSONAL DONOR STATUS 



TABLE 8 
DISCUSSION WITH PATIENTS 



Slttuj 




S 


umcrr 


rercrnl 


fnyricianr' Answer 


A umber 


Fit, m, 


Already 






40 


7.4 


Discusi with all 


143 


264 


Willing 






29J 


54 1 


Disi iin with moribund 


I9C 


36 2 


Hesitate 






113 


208 


Discuss with family 


127 


234 


Rrl»« 






79 


14 6 


Not discuss 


SI 


5.7 


Dislike 






4 


0.7 


Forbid 






Not inawrt 


fd 




19 


24 


Nor answered 


'S 


8 J 



license. Such a move should increase signifi- 
cantly the number of donors within the state. 
It is also of note that those physicians in 
house staff and faculty positions have a higher 
proportion who are already or are willing to be 
signers of the Gift Act card. These findings 
may reflect that more exposure to transplant 
programs stimulated interest and led to knowl- 

TABLE 7 
FAMILY DONOR STATUS 



Already 

Encourage 

Neutral 

Discourage 

Forbid 

Not inhered 



A'umber 
22 

172 

331 

9 

I 



I'ercenl 

4.1 
31.7 
61 I 

17 

0.2 

1.3 



edge of the need for potential donors. Al- 
though \ounger physicians appear more 
optimistic than older physicians concerning 
transplantation as effective treatment, a small- 
er percentage of them discuss the Anatomical 
Gift Act with their patients. This finding mav 
relate to the latter's greater life experience and 
ease with patients, and perhaps to an accept- 
ance of death not present in the younger 
physician. 

Reference! 

I. Cleveland SE. Johnson DL: Motivation and readiness of 
potential human tissue donors and nundonon. Piychoiom 
Mid 32:225 231. 1970 

2 Fellner CH. Schwartt SH: Altruism in disrepute : medical . 
versus public attitudes toward the living organ donor. .V 
Engl J Med 284 582 585. 1971 

3 Tilrauss RM: The Gift Relationship, from Human llluo.l 
to Socio/ Policy. New York, Pantheon DooLs. 1971 

4. Cullen WH, Garrison CE: Factors influencing |..ichr.- 
logical response to mailed questionnaires Health Srn> Rr;> 
88 M0 514. 1973 



♦46 



SOUTHERN MEDICAL JOURNAL, APRIL 1975— Vol 68, No. 4 



58 



ATTACHMENT NUMBER TWO 

CRITICAL CARE UNIT NURSE SUPERVISOR SURVEY 

During the first quarter of 1981, the attached survey form was mailed to the 
nursing supervisors of 6 emergency rooms and 12 intensive care units in 7 hospi- 
tals in Memphis. Responses were received from the nursing supervisors of 2 
emergency rooms (4 failed to respond) and 11 intensive care units (only one 
failed to respond) in 7 hospitals. 

Although the numbers involved in this survey were small, an insight was 
gained into the perception of organ donation aspects by nursing supervisors 
representing greater than 250 critical care nurses. 

Question I. results indicated a reasonably good familiarity with hospital 
policies concerning cadaveric organ donation. There appeared to be less cer- 
tainty, however, when questioning whether staff were familiar with the policy 
or whether procedures had been implemented to assure compliance. 

The results of Questions II., III. and IV. are self-explanatory. The 10 
"never" responses in Question V. would appear to be alarming until it is 
realized that no patient's personal effects are retained in an intensive care 
unit. 

If the responses in Question VII., "most of the time" and "sometimes" are 
read as "more than 50% of the time" and "less than 50? of the time", respec- 
tively, then in about half the units responding the perception is that organ 
donation is mentioned more than half of the time while in the remaining half of 
the responding units organ donation is discussed with families in less than half 
of the eligible cases. 

Question VIII. refers to a bi-monthly newsletter produced and distributed by 
the Transplant Coordinator to critical care nurses, physicians, social workers, 
hospital chaplains and hospital administrators. The last issue was distributed 
in May, 1982. Since that time, there has not been a single inquiry concerning 
the whereabouts of subsequent issues. 

Question IX. refers to a pamphlet designed to give to families of a patient 
dying or deceased who is medically eligible for organ donation. This pamphlet 
had been distributed previously to all 18 units surveyed. 

Question X. is self-explanatory. Question XI. concerns itself with the matt 
er of inservice educational seminars with critical care nurses in order to fami- 
liarize them with the various aspects of their participation in organ procure- 
ment. As a matter of practice, it is difficult if not impossible to be 
permitted to provide inservice seminars in any critical care unit more often 
than semi-annually. Obviously, if less than 50% of the nurses employed in a 
unit attend each inservice seminar, it is not possible to acquaint all nurses 
within any unit about organ donation within any year. Indeed, experience has 
shown that less than 50% of the nurses in any critical care unit in Memphis have 
ever attended an inservice program dealing with cadaver kidney donation. 

The final question ties in with Question XI. demonstrating that rarely are 
nurses afforded the opportunity to learn about organ donation. 



39 



Hospita l Unit Name 

N.A.=Not Answered 

I. Does your institution have a policy regarding cadaver kidney donation? 

Yes lQ No 3 

A. If yes, have all your staff read the policy statement? Yes 6 No 4 N.A. 3_ 

B. If yes, has your unit implements procedures to assure compliance 
within the policy statement? Yes 5 No 3 N.A. 5_ 

II. Does your institution have recommended criteria for brain death deter- 
mination'' Yes 8 No 3 N.A. 2_ 

A. If yes, are staff and physicians attending within your unit aware of 
Ihese criteria? Yes 8 No N.A. 5 

III. Is your staff aware of the death circumstances compatible with cadaver 
kidney donation'' All are aware 1 Most 11 Some 1 None 

IV. Is your staff aware of the medical suitability criteria for cadaver kidney 
donation? All are aware 1 Mos t 10 Some 2 None 

V. Does your unit search for a signed organ donor card on dead or dying 
patients'' All of the time Q Most of the time 1 Sometime s 2 Never 10 

VI. Who usually approaches the families of patients dying of a neurological 

insult concerning kidney donation? Attending Physician 7 Nurse 3 Other 

"Either" 3 

VII. How frequently are the families of patients dying of a neurological insult, 
Lut otherwise medically suitable kidney donors approached 9 

All of the time Most of the tim e 6 Sometimes 5 Rarel y Never 1 

"Unknown" 1 

VlILDo you receive copies of the monthly U.T. Transplant Program Newsletter 9 
Yes 11 No 2 
A. Does all your staff read these newsletters'' Yes 4 No 5 Most 1 Some 2^ 

N.A. 1 

IX. Does your unit have a supply of "Gift of Life" pamphlets designed to give to 
families of potential cadaver kidney donors? Yes 4 No 9 

A. If yes, are all your staff aware of their placement in lhe unit 7 Yes 3 No ^JN.A. 9 

B. Also, if yes, how frequently are the pamphlets vised'' In every case 
Most of Hie time Q Sometimes 4 Neve r 

X. Ilov. would you describe the attitudes of your staff towards cadaver kidney 
donation'' Favorable 9 Neutral_4_ Opposed 

A. How would you describe the attitudes of most neurosurgeons attending 
within your unit? Favorable 9 N eutral 3 Opposed N.A. 1^ 

B. How would you describe the attitudes of other physicians attending patients 
dying of a neurological insult? Favorable__7__Neutra l 4 Opposed 

N.A. 2 

XI. When was the last time an inservice seminar concerning cadaver kidney donation 
was conducted for members of your staff? < 3 mos. ago 3 3-Gmos. ago 1 
tmos.-l yr ago 4_ > 1 yr. ag o 4 "Probably Never" 1 

A. What proportion of your staff attended the last inservice session' 

< 10% 1_10%-20% 2 25%- 50 % 3 50%-75 % 3 75%- 100% 1_N.A. 3 

XII. Do your new nurse orientation procedures provide a segment dealing with 
cadavo.- kidnev procurement? Yes 4 N o 9 



40 



Hoepita l Unit Name 

I Does your institution have a policy regarding cadaver kidney donation? 
Yes _ No 

A. If yes, have all your staff read the policy statement? Yes _ No 

B. If y es , has your unit implements procedures to assure compliance 
within the policy statement? Yes _ No 

]i Does your institution have recommended criteria for brain death deter- 
mination? Yes No 

A. If yes, are staff and physicians attending within your unit aware of 
these criteria? Yes No 

HI. Is your staff aware of the death circumstances compatible with cadaver 
kidney donation' All are aware Most Some None 

IV. Is your staff aware of the medical suitability criteria for cadaver kidney 
donation? All are aware Most Some None 

V. Does your unit search for a signed organ donor card on dead or dying 
patients' All of the time Most of the time Sometimes Never 

VI. Who usually approaches the families of patients dying of a neurological 
insult concerning kidney donation? Attending Physician Nurse Other_ 

VII How frequently are the families of patients dying of a neurological insult, 
but otherwise medically suitable kidney donurs approached? 
All of the time Most of the time Sometimes Rarely_ 



Never 



No 



'.ill. bo yuu receive copies of the monthly U.T. Transplant Program Newsletter" 

Yes No 

A. Does all your staff read these newsletters? Yes No 

IX. Does your unit have a supply of "Gift of Life" pamphlets designed to give to 

families of potential cadaver kidney donors 9 Yes No 

A. If yes, are all your staff aware of their placement in the unit' Yes_ 
II. Also, if yes, how frequently arc the pamphlets used'' In every case 

Most uf the time Sometimes Neve r 

X. llov. would you describe the attitudes of your staff towards cadaver kidney 
donation? Favorable Neutral_ Opposed 

A. How would you describe the attitudes of most neurosurgeons attending 
within your unit? Favorable Neutral Opposed 

II. How would you describe the attitudes of other physicians attending patients 
dying of a neurological insult? Favorable Neutral Opposed 

XI. When was the last time an inservice seminar concerning cadaver kidney donation 
v,as conducted for members of your staff? < 3 mos. ago 3-6mo6. ago 

( mos. - 1 yr ago > 1 yr . ago 

A What proportion of your staff attended the last inservice session'' 
< 10% 10%-20% 25%-50% 50%-75% 75%- 100% 

XII. Do your new nurse orientation procedures provide a segment dealing with 
cadaver kidnev procurement? Yes No 



41 



ATTACHMENT NUMBER THREE 



A STUDY TO IDENTIFY POTENTIAL ORGAN DONOR AVAILABILITY 

During the period of April through August, 1981, in cooperation with the 
Organ Procurement Unit of The Center for Disease Control, a study of the charts 
of patients dying in 12 acute care hospitals during calendar year 1980 within a 
15 mile radius of The University of Tennessee-Memphis was conducted in order to 
assess the potential availability of organ donors. 

' A chart reviewing instrument (containing this center's specific organ donor 
medical acceptability criteria) was developed in concert with the C.D.C. Mr. 
Michael Rich of the C.D.C. and Gary Hall, U.T. Transplant Coordinator visited 
the various hospital administrators to obtain consent for the conduct of the 
study. All hospitals agreed to participate. 

The study was actually conducted by Gary Hall and was divided into four 
phases: (1) Death Register Tabulations; (2) Patient Chart Review; (3) 
Tabulation and Analysis of Chart Review Results; and (4) Report of Review 
Results and Analysis to Participating Institutions. 

l - Death Register Tabulation . In preparation for the actual chart review, 
the Death Register for Emergency Room and In-hospital Deaths for each 
of the 12 hospitals was reviewed. Patients dead on arrival were 
excluded from the tabulations. Of the remainder, those deaths of 
patients whose ages were less than one or greater than 59 years of age 
were excluded. Finally, those deaths in which the Death Register noted 
a cause of death (e.g. cancer, infection, etc.) which is a contrain- 
dication to organ donation were excluded. 

11 • Chart Review Results . Six hospitals were selected for inclusion in 
this phase of the study. These six institutions accounted for 330 
emergency room deaths and 4,463 in-hospital deaths or approximately 80% 
of the total deaths tabulated from the 12 hospitals' death registers. 
After the actual chart review was initiated, one of the hospitals was 
eliminated from this phase when it was found that the patient charts 
contained inadequate documentation to permit a reliable assessment of 
any specific patient's medical suitability for organ donations. That 
hospital's data (representing 110 emergency room deaths and 620 in- 
hospital deaths) was then combined with the Death Register Data from 
the six hospitals not selected for actual chart review. 

The actual number of patient charts reviewed is indicated in the first 
column of Section II. on the attached, "Chart Review Results" sheet. All 25 
remaining emergency room death charts and 316 charts of patient dying after 
admission to the hospital were reviewed (fourteen charts selected for review 
were unavailable at the time of the review and another 57 charts from a single 
institution were randomly selected out from the review since their inclusion 
would have resulted in exceeding the preagreed limit of 150 charts for review 
from a single institution). 



42 



Under the category of "Donors" in Section II. of the attached "Chart Review 
Results" sheet are three columns which relate the chart review findings to 
actual results in 1980. The "Identified" column denotes those deaths in which 
the chart review found medically accepted brain-dead individuals (16 donors were 
included in this column to account for the expected incidence among the 71 
patient charts not reviewed). Charts of patients which had insufficient data or 
in which there was not a clear indication of the existence of brain-death were 
excluded. The "referred" column indicates the number of referrals of patients 
who were medically acceptable for organ donation to the transplant program from 
the five hospitals reviewed. The final column "Recovered denotes the number of 
such referred patients who actually became donors. 

The results obtained from the above review and tabulations were then applied 
to the Death Register Tabulations from the other seven hospitals in which an 
actual patient chart review was not conducted. These results were reflected in 
Section II. a. of the attached "Chart Review Results" sheet. 

Since there is no difference between the two groups of hospitals in terms of 
the character of emergency room patient characteristics, a factor of 5% (the 
proportion of E.R. deaths in Section II. found to be suitable for organ 
donation) was applied to the E.R. deaths tabulated among the seven hospitals in 
which the review was not conducted. In-hospital patient characteristics within 
this qroup of seven institutions (with the exception of two hospitals repre- 
senting a total of approximately 800 in-hospital deaths) is not the same as in 
the five institutions actually reviewed. Accordingly, the proportion of in- 
hospital deaths found to be suitable for organ donation 2.3+%) among the five 
institutions actually reviewed was arbitrarily cut in half (1.2%) when applied 
to the seven hospital group's data. 

The resultant data included in Section III. (Combined Totals) is felt to be 
a conservative assessment of the actual potential availability of donors among 
the twelve acute care hospitals studied for calendar year 1980. 

CONCLUSIONS: The incidence of medically acceptable cadaveric organ donors 
in M emphis, l enn essee, in calendar year 1980 was determined to be 140 (2.3% of 
6 154 tabulated hospital deaths). During calendar year 1980 35 patients (an 
estimated 25% of those available) who were medically acceptable for organ dona- 
tion were referred to the Transplant Program. Thirteen patient fami les (37%) 
refused organ donation with the result that 22 patients (63%) actually were 
donors. The documented estimated referral efficiency (25%) does not account for 
those cases where hospital personnel approached patient families about organ 
domation, were refused and never therefore , contacted the Transplant Program. 
However, candid conversations with key critical care nursing personnel support 
the inescapable conclusion that a majority of suitable donors are never iden- 
tified by attending hospital and medical staff and their families are not 
advised of their right to donate. 



43 



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45 



ATTACHMENT NUMBER FOUR 

SURVEY OF CRITICAL CARE NURSES' ATTITUDES 

TOWARDS ORGAN PROCUREMENT 

A survey of critical care nurses' attitudes towards the various aspects 
of organ donation and organ procurement was conducted during the late 
autumn of 1982. Four hundred survey forms (a sample of which is attached) 
were distributed through the unit nursing supervisors in 10 emergency 
rooms and 18 intensive care units in 11 hospitals with instructions for 
the form's completion and return of the surveys to Gary Hall, U.T. Transplant 
Coordinator. One hundred Seventy-five completed surveys from 6 emergency 
rooms and 7 intensive care units in 7 hospitals were returned. One 
hospital (representing one E. R. and two intensive care units) refused 
to participate. Effforts to retreive the surveys from the remaining 3 E. R.'s 
and 9 intensive care units were abandoned after repeated attempts. 

On the attached sheets are tabulated the responses in percentages for each 
question. The last column tabulates the responses for all participants. In 
the first four columns, responses are stratified according to the participants' 
responses to two key questions- Question 4 under "Organ Donation Information" 
("Attitude toward organ donation after my death") and Question 3 under "Brain 
Death Information" hereinafter referred to as Question 3, Section II. The first 
four questions are keyed as follows: Column I-those respondents who marked 
"a" or "b" in Question 4, Section I and "yes" to Question 3, Section II; 
Column II - those respondents who marked "a" or "b" in Question 4, Section I 
and "no" on Question 3, Section II; Column III - those respondents who marked 
"c" or "d" on Column 4, Section I and "yes" on Question 3, Section II; and 
Column IV - those respondents who marked "c' or "d" on Question 4, Section I 
and "no" on Question 3, Section II. The columnar percentages in each 
question will not necessarily total 100% since the percentages listed 
indicate the proportion of survey forms on which that choice was selected, 
thereby accounting for more than one choice selected per question. 

Analysis of the responses according to demographics has not been noted here 
due to the following: (1) Age - no significant differences were found by 
age grouping; (2) Sex - all but seven of those indicating their sex were 
females; (3) Race - all but 12 of those indicating their race were white; 
(4) Religion- all but 27 of those indicating their religion were Protestant, 
and (5) Position - 141 of the 175 respondents were registered nurses. 

A detailed analysis of the results will not be related here, but several 
findings of importance and relevance will be noted. These findings suggest 
that nurses' personal attitude toward organ donation and/or brain death do 
impact on their willingness to participate 1n organ procurement. This conclu- 
sion is confirmed by reviewing the results of the following questions: 

(1) Question 2, Section I - under Column IV, 56% of the respondents 
indicated they felt organ donation to be either valid only if the 
patient has a signed organ donor card or "a fruitless and nonproductive 
act." 



46 



(2) Question 3, Section I - about 90% of the respondents under columns I and 
II (those with a favorable attitude toward personal organ donation) indicated a 
willingness to take affirmative, independent action to encourage organ donation 
with their patients or their families compared to only about 45% of the respon- 
dents under columns III and IV (those with unfavorable attitudes toward personal 
organ donation) who would take such action. 

(3) Question 7, Section I - this question concerns the nurse's perception of 
the frequency with which the families of patients under their care who are 
medically suitable for organ donation are approached. The most distressing 
finding is that 76% of all respondents indicated that families of potentially 
eligible organ donars are approached "sometimes", "rarely", or "never"! 
Another way of expressing this point is that three quarters of the nurses 
perceive that less than half the eligible patients under their care ever 

have an opportunity to become donors. 

In addition to nurses' inhibitions to unequivocal participation in organ 
procurement emanating from personal attitudes toward organ donation and 
brain death, Question 9, section I indicates considerable uncertainty as to the 
hospitals' postion with respect to organ donation. Although this fact does 
not solely account for considerable uncertainty regarding eligible donor 
identification (as determined from the responses to question 10 ( and 11), 
it would seem to follow that if one is not sure of his employer's 
position or support for a program, he is less likely to acquaint himself 
with that program's needs and requirements. 

Finally, the results of this survey do serve to reassure this transplant 
program that their exists in Memphis widespread medical community support for 
and participation in facititating organ donation. However, the survey confirms 
our conviction developed from the previous hospital patient death chart 
review that a majority of eligible donors are never identified and the 
families not offered the organ donation option. 



47 



TABLUATED RESULTS 
CRITICAL CARE NURSES' SURVEY 



ORGAN DONATION INFORMATION 










1.(80) 


11.(30) 


111.(22) 


IV. (27) 


TOTAL (175) 


1. a. 


41% 


40% 


23% 


15% 


33% 


b. 


60% 


47% 


77% 


63% 


58% 


* c. 


1% 


10% 


5% 


7% 


4% 


d. 





3% 





11% 


3% 


n.a. 


1% 





5% 


4% 


3% 


2. a. 


69% 


67% 


50% 


30% 


58% 


b. 


20% 


17% 


32% 


11% 


21% 


c. 


10% 


20% 


14% 


52% 


19% 


d. 











4% 


1% 


n.a. 


1% 





5% 


4% 


3% 


3. a. 


39% 


40% 


14% 


7% 


26% 


b. 


48% 


57% 


32% 


37% 


41% 


c. 


34% 


40% 


68% 


52% 


34% 


d. 


1% 


3% 


5% 


7% 


3% 


n.a. 


1% 








4% 


5% 


4. a. 


70% 


47% 


_ 


_ 


42% 


b. 


30% 


53% 


- 


- 


24% 


c. 


_ 


_ 


64% 


74% 


22% 


d. 


_ 


_ 


36% 


26% 


10% 


n.a. 


- 


- 


- 


- 


3% 


5. a. 


64% 


50% 


32% 


41% 


51% 


b. 


28% 


23% 


9% 


7% 


19% 


c. 


10% 


27% 


50% 


41% 


25% 


d. 








9% 


11% 


3% 


n.a. 














1% 


6. a. 


38% 


37% 


18% 


19% 


30% 


b. 


52% 


47% 


59% 


41% 


52% 


c. 


6% 


3% 


9% 


11% 


7% 


d. 


1% 


17% 


9% 


22% 


8% 


e. 


30% 


30% 


45% 


26% 


34% 


f. 


25% 


20% 


23% 


11% 


19% 


9- 


4% 





5% 


4% 


5% 


h. 


4% 





5% 


4% 


3% 


n.a. 


1% 


7% 








3% 


7. a. 


1% 











2% 


b. 


20% 


3% 


5% 


4% 


19% 


c. 


42% 


47% 


27% 


15% 


46% 


d. 


16% 


40% 


41% 


44% 


27% 


e. 


4% 


7% 


23% 


41% 


3% 


n.a. 


2% 


3% 


5% 





4% 



48 

TABULATED RESULTS 
CRITICAL CARE NURSES' SURVEY 



ORGAN DONATION INFORMATION 





1.(80) 11.(30) 


111.(22) 


IV. (27) 


TOTAL (175) 


8. a. 


8% 


13% 


9% 


19% 


14% 


' b. 


4% 


10% 


32% 


19% 


12% 


c. 


2% 





- 


4% 


2% 


d. 


5% 





5% 


4% 


5% 


e. 


72% 


70% 


18% 


30% 


53% 


f. 


8% 


3% 


27% 


22% 


11% 


n.a. 


2% 


3% 


9% 


11% 


7% 


9. a. 


55% 


47% 


41% 


26% 


47% 


b. 


1% 


3% 


9% 


7% 


3% 


c. 


44% 


50% 


45% 


63% 


46% 


n.a. 








5% 


4% 


3% 


10. a. 


71% 


40% 


64% 


33% 


57% 


b. 


29% 


60% 


32% 


67% 


41% 


n.a. 








5% 





3% 


11. a. 


68% 


33% 


55% 


48% 


54% 


b. 


30% 


63% 


41% 


52% 


41% 


n.a. 


2% 


3% 


5% 


~ 


5% 


BRAIN DEATH INFORMATION 










1. a. 


9% 


3% 





7% 


6% 


b. 


66% 


67% 


73% 


48% 


63% 


c. 


24% 


13% 


23% 


33% 


22% 


d. 





3% 


5% 


15% 


3% 


n.a. 


1% 


13% 





4% 


7% 


2. a. 


69% 


90% 


73% 


67% 


69% 


b. 


19% 


3% 


27% 


22% 


17% 


c. 

















d. 


11% 


7% 





4% 


9% 


n.a. 


1% 








7% 


5% 


3. a. 


100% 





100% 





59% 


b. 





100% 





100% 


34% 


n.a. 














7% 



n. a. = not answered 

numbers 1n parenthesis next to the column headings denote number of 
respondents in each category. 



49 



Dear Colleague: 

The maintenance of a viable organ retrieval program is essential in the effort 
to meet the needs of the many victims of end-stage organ failure who'are currently 
waiting for the chance to be transplanted in the greater Memphis region. Fundamental 
to the success of this program is the willingness of acute care personnel to participate 
in the referral of potentially suitable organ donor candidates. As a member of an 
acute care team, your opinions and perceptions of the various elements involved in 
solid organ donation are vitally important. 

Attached is a confidential questionnaire designed to gather your impressions. 
Please take a few brief moments to candidly give us your opinions and return the com- 
pleted form to your unit supervisor. Your responses will be used to help us become 
more aware of your satisfaction with the program and thereby help us to improve our 
performance. Please feel free to add any additional comments or suggestions. 

Thank you very much for your time and cooperation. 




mA . 

(ry^HalirVTransplant Coordinator 
Renal/Hepatic Transplant Progran 

SOLID ORGAN DONATION QUESTIONNAIRE 



GENERAL INFORMATION 



1. Your Age: 2. Sex: 

3. Race: 4. Religion (optional) 

5. Position (RN, LPN, etc.) " 

6. Years in practice 

7. Hospital: 



8. Unit (e.g. 10th floor, ICU) : 

ORGAN DONATION INFORMATION 
(Please check only one response) 

1. Cadaveric solid organ transplantation is: 

a. Effective and proven. 

b. Effective in selected cases. 



A. Attitude toward organ donation after my 
death: 



_a. Organ Donor Card signed. 

_b. Have not signed card, but willing to. 

_c . Would not sign card, but idea of 

donation acceptable if my family agi 
_d. Opposed to organ donation after my 

death. 



_c. Experimental, but soon to be proven. 
d. Dangerous, no clinical value. 



2. I consider organ donation to be: 



5. Concerning organ donation of a member of 
my family: 



_a. I have discussed organ donation with 

them and am willing to follow their 

wishes. 
_b. I would be willing to donate their 

organs even though I have not discussed 

it with them. 
_c. I have never thought about consenting 

to organ donation for a family member. 

_d. I would never donate their organs, 
regardless of their intentions. 



a. A valid and humanitarian act in 

all eligible cases. 
_b. A valid and humanitarian act for the 

family even if patient's wishes unknown 
_c. A valid and humanitarian act only if 

patient has signed donor card. ~ 
_d. A fruitless and nonproductive act. 



3. Concerning patients under my care: 
(Check any) 



_a. Would encourage them to sign organ 

card. 
_b. If moribund, would encourage family to 

consent to donation. 



6. The request of organ donation should be 
made: (Check any) 



a. In every eligible case. 
_b. Only after the family accepts that the 

patient will not survive. 
_c. Only if family is not too upset. 
_d. Only if family requests it. 
_e. By patient's physician. 
_f. By patient's nurse 
_g. Only by a member of retrieval team. 



h. Other 



, _ 7. How frequently are the families of patients 
c. Would refer such patients and families to 



retrieval program for their guidance. 
_d. Would never discuss matter with patients 
or families nor refer them to organ ret- 
rieval program. 



under your care who are medically 
eligible for donation approached? 



a. Always; b. Most times; 

_ c - Some times; d. Rarely; 

e. Never. 



50 



8. My Personal reservations about organ 
donation are: 



a. I may not really be dead when my 
organs are removed. 

b. I can't accept the idea of my body 
being "cut on" after I die. 

c.'l am dubious about the worth of 
organ donation. 

d. lire doctors will not be aggressive 
-in treating while I'm alive if I'm 

an organ donor. 

e. No reservations. 
~f. Other 



9. Does your hospital have a policy regard- 
ing solid cadaveric organ donation? 

a. Yes; b. No; c. Don't know 



10. Are you aware of the death circumstances 
compatible with cadaveric solid organ 
donation? 

a. Yes; b. No. 

)]. Are you aware of the medical suitability 
criteria frr cadaveric solid organ donat- 
io rib? 

__a. Yes; b. No. 

iil '.MN UKATH JNTO I IMATION (Check one) 

]. The criteria physicians use in my hospital 
to declare brain death are: 



a. Absent respirations, fixed-dilated pup 
ils, no response to painful stimuli. 

b. Al] of ^. above and flat IXC's or 
angiography. 

c. Depending on circumstances, either a. 
or b. 

d.. No standard criteria. 



2. The patient Jeclared brain dead should: 

a. He removed from artificial support 

only after the family consents to it. 

b. Be removed from artificial support 

without involving the family in the 
decision. 
c. lie treated aggressively regardless of 
tiie family's wishes. 
d. Other 

J. In my opinion, it is acceptable to remove 
a brain-dead donor's organs after the pat- 
ient is declared brain dead and before the 
heart stops beating: 

a. Yes; b. No. 



Comments and Suggestions: 



51 

Mr. Gore. I am going to hold my questions to the panel to a 
minimum, and I would ask my colleagues to do so as well, because 
of the doctor's travel plans. 

First of all, just briefly, we are going to go into the specific sug- 
gestions that you, Dr. Williams and you, Mr. Hall have provided to 
us in detail later in this hearing today and tomorrow. But I want 
to elicit from you two points. 

First of all, Dr. Williams, your experience is that of a doctor who 
spent, I believe, 6 weeks under Dr. Starzl and then came back and, 
on your own, upgraded the skills that you learned in a relatively 
brief time with Dr. Starzl and then implemented this new program 
at the Medical Center in Memphis. That experience suggests that 
we are likely to see a dramatic increase in the number of centers 
and in the number of transplant operations in the next few years 
all across the country. Is that correct? 

Dr. James Williams. Yes. 

Mr. Gore. As a result, the demand for transplantable organs is 
likely to increase dramatically as well; is that correct? 

Dr. James Williams. Yes. 

Mr. Gore. And the experiences that Mrs. Hall has had and that 
Captain Broderick has had are going to become quite commonplace 
in the United States unless we figure out a way to respond to it on 
a national basis; is that correct? 

Dr. James Williams. Yes. 

Mr. Gore. All right. 

One of the hurdles that your patients face is money. You have 
got the problem of paying for the operation, you have the problem 
of procuring the transplantable organ, and you have the problem of 
insufficient awareness on the part of the American people as to 
how important it is for people to be willing to donate organs after 
they die; correct? Those are the three hurdles? 

Dr. James Williams. Yes. 

Mr. Gore. In your case, Captain Broderick, you face that first 
hurdle. Your child can't qualify as a candidate in this particular 
program because you don't cross that first threshold. You don't 
have a way to pay for the operation. You are an active-duty cap- 
tain in the U.S. Army, and the U.S. Government refuses to pay the 
amount of money necessary to save your child's life. Is that cor- 
rect? 

Captain Broderick. Yes, sir. 

Mr. Gore. I find that really hard to believe. Without objection, I 
would like to put into the record of this hearing a letter from the 
Assistant Secretary of Defense, Dr. John F. Beary III, to you, Dr. 
Williams, where he says a second consideration in denying approv- 
al of this procedure is the fact that other federally funded health 
programs, as well as other third-party payers, consider the proce- 
dure to be investigational. An additional concern is the high cost of 
the procedures, typically $50,000 to $60,000, versus the expected 
long-range benefit to be derived. 

[The information follows:] 



52 




ASSISTANT SECRETARY OF DEFENSE 



WASHINGTON. D C 20301 



4 WAR 1S63 



J F_ ALTH AFf AIFU 



James W. Williams, MD. 

Associate Professor 

The University of Tennessee, 

Center for the Health Sciences 
Memphis, Tennessee 38163 

Dear Dr. Williams: 



Lieutenant General Mittemeyer, in response to your December 3, 1982 letter, 
has asked me to review our policy regarding coverage of liver transplants by 
CHAMPUS. Although there is no question that there are patients who have 
derived benefit from liver transplants,, there are several factors I have 
considered which lead me to conclude that the procedure is still properly 
classified as investigational. 

First, there are very few facilities in the United States which have liver 
transplant programs. Although the University of Pittsburgh, for example, has 
had great success with liver transplants, a number of other facilities have 
had high mortality rates in performing the procedure. Thus, since the 
procedure cannot be readily replicated nor be provided with a predictable 
level of success at a significant number of facilities, it does not meetTthe 
"generally accepted standards of usual professional medical practice in the 
general medical community" criteria required to be a covered service under the 
CHAMPUS program. 

A second consideration is the fact that other federally funded health programs 
as well as other third-party payors also consider the procedure to be 
investigational. An additional concern is the high cost of the procedure, 
typically 450,000-60,000, versus the expected long-range benefit to be derived. 

It is unfortunate that denying liver transplants as a covered service under 
CHAMPUS will result in hardships on some of our service members. However, in 
keeping with ray responsibilities as Acting Assistant Secretary of Defense for 
Health Affairs, I cannot recommend that CHAMPUS benefits be expanded to cover 
liver transplants until the procedure becomes more widely accepted and 
practiced by the medical community. We must attempt to assure that high 
quality care is provided to our beneficiaries in all situations. 

I appreciate your concern in this matter. 




F. Beary, III, M.D. 
Acting Assistant Secretary 



cc: Lieutenant General Mittemeyer 



53 

Mr. Gore. I share your reaction to that as repugnant, Captain 
Broderick, and I will recommend at the conclusion of this hearing 
today — not waiting for the committee report — that this subcommit- 
tee immediately, as a subcommittee, call upon the U.S. Govern- 
ment and the Defense Department who runs this CHAMPUS pro- 
gram to immediately change its policy and allow for the payment 
for this procedure. It is not investigational or experiemental. It is 
necessary to save your child's life. I will ask my colleagues to join 
in that recommendation later today. 

Mr. Hall, it is true, is it not, that with so many patients, with so 
many people needing organs to be donated, that the availability of 
funds is a factor that institutions take into account — they must, of 
necessity, take that into account; is that correct? 

Mr. Gary Hall. That is correct. 

Mr. Gore. As Mrs. Hall leaves and gets on the plane to fly back 
to Memphis, Captain Broderick is still faced with the problem of 
trying to pay for this operation. This really shouldn't be a consider- 
ation for professionals such as you and Dr. Williams; is that cor- 
rect? 

Mr. Gary Hall. No, it shouldn't. 

Mr. Gore. All right. I am sorry to rush through my questions, 
but because of the time constraint, I wanted to do that. 

Congresswoman Schneider. 

Mrs. Schneider. Thank you. 

I would like to know from any member of the panel if you are 
aware of whether or not the American Medical Association or the 
American Hospital Association is intimately involved in developing 
uniform policy? 

Mr. Gary Hall. We have no knowledge of that at this time. 

Mrs. Schneider. And the AMA is not involved in a uniform 
policy? 

Dr. James Williams. Not that I am aware of directly. 

Mrs. Schneider. It certainly seems to me that that is one good 
place to start. I don't know that this body would be in a position or 
even inclined to make mandatory requirements on the hospitals, 
but it seems that you folks have certainly delineated how we could 
get around this problem. 

I am anxious to know how we in Congress might be able to assist 
you, Mr. Hall, in improving the rate of donation of organs for 
transplant surgery? Is there something we could do in this body? 

Mr. Gary Hall. I thought about that. I don't know that any sort 
of mandatory regulations are in order. I think that this body can 
be influential in encouraging the various parties that have to coop- 
erate in an organ procurement procedure to get together at a na- 
tional level and at the various regional and local levels to try to 
come to grips with solving the problems of oversight and omissions 
that occur every day in this country, in that donors are not identi- 
fied, and a family is not offered the option to donate. 

Dr. James Williams. If I might add just one comment to what 
Mr. Hall said, it is a problem of education, educating the public. 
There is not a person in this group here who, when they die, there 
will be any question about what happens to their organs. We know 
what can happen. The general public doesn't know. The technology 
has rapidly advanced. People who are now of child-bearing age and 



54 

of donor age were educated at a time when liver transplantation or 
heart transplantation did not occur. So, the technology, I think — 
the feasibility of doing these things has not been disseminated, it is 
not understood. So it is clearly a matter of public education. 

Mrs. Schneider. Obviously, the public media has an enormous 
role to play, more so than the Members of Congress. 

I am anxious also to know about your interpretation. How long 
have we been transplanting livers, how many years? 

Dr. James Williams. I would like to leave those questions to Dr. 
Starzl, the person who is going to testify later. He is the father of 
this effort. He has taken it from the very beginning and literally 
pushed it into the position that it is today. 

Mrs. Schneider. Very fine. 

Most of my other questions, Mr. Chairman, have to do with the 
medical aspects, so I will hold my questions for the next panel. 

Mr. Gore. Fine. 

Congressman Scheuer. 

Mr. Scheuer. I will defer questions until the next panel, Mr. 
Chairman. 

Mr. Gore. Fine. 

Mr. Scheuer. I do want to say that I deeply share your sense of 
outrage and sense of deep concern about the posture of the Federal 
Government in denying this life-enhancing and life-saving therapy 
to patients who would otherwise die. 

Mr. Gore. Congressman Durbin. 

Mr. Durbin. I would just like to ask the panel in general if there 
has been any effort or discussion about putting together regional 
centers for coordination of hospital activities so that there will be, 
at least on a regional basis, some sort of outreach to small commu- 
nities and the medium-size hospitals that may not be aware of the 
need? 

Mr. Gary Hall. The organ procurement evolved as a result of 
the need for kidney transplantation, and organ procurement that is 
directed as close to home as possible has generally been found to be 
the most effective. I don't know that there are any efforts afoot to 
develop any regional programs, other than regional organ sharing 
programs which will be addressed later. 

Mr. Durbin. Thank you very much. 

I will hold any further questions for the next panel. 

Mr. Gore. Congressman Dan Glickman. 

Mr. Glickman. Thank you, Mr. Chairman. 

I would like to ask you if you think the Government should 
engage in some sort of national data bank for disclosure of organs 
for transplant? I understand there are regional networks, which 
you touched on briefly, but perhaps Mr. Hall or somebody else may 
want to talk about it. Should the Federal Government establish a 
national coordinating information data bank for available organs 
for transplant? 
Mr. Gary Hall. I can't make a judgment on that. 
Mr. Glickman. Is the existing system adequate? I understand the 
southeastern area of the United States, and Florida in particular, 
has a pretty good system. 

Dr. James Williams. I think the problem is not in matching the 
donor with the potential recipient. The problem is identifying and 



55 

getting the donor. Once the family has given permission for the re- 
moval of those organs, from then on, the existing data banks, com- 
puter banks, are able to match the suited recipient. 

Mr. Glickman. Is there anything the Federal Government can do 
to encourage donor participation? 

Dr. James Williams. Those are the things that I am not by train- 
ing equipped to say. I can identify the things I would like to have 
done, but who does it, I 

Mr. Gore. Would my colleague yield? 

Mr. Glickman. Yes. 

Mr. Gore. The third panel today is going to provide us with a 
number of suggestions, some of which the subcommittee will be in- 
cluding in its recommendations, I anticipate. 

Following up on your question to Mr. Hall about a nationwide 
system, how many separate organ procurement systems did you 
contact in Brandon Hall's case, Mr. Hall? 

Mr. Gary Hall. It was in excess of 30. 

Mr. Gore. So you have to go to 30 separate organ procurement 
networks in your search for an organ for this child. 

How many organs are available for transplant but are unusable 
because they don't get matched with a recipient in time? Isn't it 
about 25 percent? 

Mr. Gary Hall. That is true with kidneys. It is not quite that 
high. But that is true with kidneys. I have no information relative 
to other organs. 

Mr. Gore. No figures on livers? 

Mr. Gary Hall. Those that are actually excise and not used. 

Mr. Gore. Presumably that percentage could be reduced if we 
had one network instead of you having to search through 30 sepa- 
rate networks; is that a reasonable assumption? 

Mr. Gary Hall. The figure of 20 percent is really not an accu- 
rate figure. Most of those organs that are discarded are not discard- 
ed for lack of finding an available recipient, they are discarded for 
other reasons. Only about a 5-percent figure is a more accurate 
figure for organs discarded for lack of an available recipient at a 
specific time. 

Mr. Gore. I see. 

Before closing, Mrs. Hall, I understand that three of Brandon's 
nurses from LeBonheur Hospital paid their own way to come to the 
hearing today with you and Brandon. Have you been receiving 
pretty good medical treatment back in Memphis? 

Mrs. Billie Hall. We always received good medical treatment at 
LeBonheur. You wouldn't believe how good they are to us. 

Mr. Gore. Captain Broderick, I understand that Adriane's case 
has attracted the interest and attention of the White House, and 
you have received some special attention there; is that correct? 

Captain Broderick. I personally have not had any contacts with 
the White House, sir. 

Mr. Gore. I didn't ask that question to elicit that answer. It was 
based on a mistaken assumption. I do know that they have an om- 
budsman over there who works practically full time just on this 
matter. 

Dr. Williams? 



56 

Dr. James Williams. Yes; we have been in contact with Mr. 
Battan, and it appears as though the President is very interested in 
this problem and is applying pressure to CHAMPUS as well. 

Mr. Gore. We are going to apply some pressure today. I hope and 
expect a unanimous subcommittee action. 

Let me thank all of you for helping in this effort to improve the 
system for acquiring organs for transplantation. 

We wish you good luck and God speed, Mrs. Hall and Brandon. 

Mrs. Billie Hall. Thank you. 

Mr. Gore. Captain Broderick, we will be doing everything we 
possibly can to assist you in your continuing efforts on behalf of 
your daughter, and also on behalf of other families around the 
country that are in this same predicament. 

Captain Broderick. Thank you very much, sir. 

Mr. Gore. Thank you all. 

Our next witnesses include some of the most distinguished doc- 
tors in the entire world. With your indulgence, and you have al- 
ready shown us a great deal, I must tell you that we have a vote on 
the floor of the House. We will recess for approximately 6 minutes, 
and then we will come back. 

[Recess.] 

Mr. Gore. The subcommittee will come back to order. 

We are truly honored to have on this panel distinguished physi- 
cians. Dr. Shumway and Dr. Starzl are truly the pioneers in their 
respective fields, the leading transplant surgeons in their world. 
Dr. Shumway almost single-handedly rescued the heart transplant 
procedure from a disappointing start in another decade and made 
it the life-saving procedure that it is today. 

Dr. Tom Starzl single-handedly pioneered the liver transplant 
procedure which, as we have heard, is becoming, if not common- 
place, then certainly a regular part of medicine's ability to save 
lives. 

Dr. G. Melville Williams, in addition to being a distinguished sur- 
geon, is the president of the American Association of Transplant 
Surgeons. 

To all three witnesses, let me extend on behalf of the subcommit- 
tee our thanks for your willingness to come and join us in this 
effort. We know it is most unusual for you, Dr. Shumway and you, 
Dr. Starzl, to speak publicly. You are often too busy in the operat- 
ing room and, for other reasons, you just don't speak out publicly. 
We appreciate very much your willingness to come here — particu- 
larly, Dr. Starzl, in light of the fact you were up all night. We don't 
appreciate you any less, Dr. Shumway. But the fact that you were 
willing to come here after having been up all night on a liver 
transplant operation really testifies to your recognition of how 
great the need is for this country to move forward. 

Without further ado, Dr. Shumway, we will begin with you. 



57 

STATEMENTS OF NORMAN SHUMWAY, M.D., PROFESSOR OF SUR- 
GERY, STANFORD UNIVERSITY SCHOOL OF MEDICINE, STAN- 
FORD, CALIF.; THOMAS E. STARZL, M.D., PROFESSOR OF SUR- 
GERY, UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE, 
PITTSBURGH, PA.; AND G. MELVILLE WILLIAMS, M.D., PROFES- 
SOR OF SURGERY, JOHNS HOPKINS HOSPITAL, BALTIMORE, 
MD. 

Dr. Shumway. Thank you. 

I speak for the entire panel that we are grateful for this opportu- 
nity to say a few things about the transplantation of tissues in 
each of our particular specialties. 

First, let me make a few general comments regarding the 
present status of heart and heart-lung transplantation. I would like 
then to focus on the somewhat special problems associated with 
heart and heart-lung donors. 

During the last decade, tremendous progress has been made in 
the science and practice of transplantation. New drugs have 
become available to control more effectively the immune response 
to transplanted tissues. As a matter of fact, since we began the use 
of cyclosporine A in December 1980, there has not been a single in- 
stance of clinically diagnosable rejection of the allografted heart. In 
other words, no patient has shown any signs of cardiac failure as a 
result of the transplanted tissue. There are some deleterious side 
effects of cyclosporine A, principally related to kidney function, but 
the drug can now be synthesized, and its nephrotoxic properties 
should soon be deleted from sister compounds. 

The developing technology for organ preservation has widened 
the pool of donors. Hearts can not be transported probably up to 
2,000 miles with every expectation that the transplant will perform 
satisfactorily immediately. Further work is progressing nicely in 
this area of research, and the day will come when hearts can be 
preserved to the same temporal limits enjoyed now by renal and 
liver grafts. 

Last year, in the United States alone, approximately 100 patients 
underwent cardiac transplantation, 30 at Stanford. The 1-year sur- 
vival rate now stands at 80 percent, and fully 90 percent of all pa- 
tients having heart transplants at Stanford leave the hospital in 
stable condition. This statistic contrasts markedly with the 22 per- 
cent 1-year survival 15 years ago, which was the first year of clini- 
cal heart transplantation at Stanford University. 

Of 260 patients having cardiac transplants, 106 at Stanford are 
alive and well now between 13 x k years and 2 weeks following the 
procedure. Suffice it to say that transplantation of the heart is now 
on the same therapeutic footing as kidney transplants. Medical 
centers all over the world are re-entering the field, and many clin- 
ics are producing results comparable to our own. This year, the 
number of transplants should at least double last year's total with 
further expansion to be expected later in the decade. 

The hospital cost for a patient having heart transplantation at 
Stanford is roughly twice that for a standard open heart surgical 
procedure at Stanford. No professional fees have ever been charged 
for any transplantation procedure, either heart or heart-lung. 



58 

Donor costs average $3,000 and are independent of whether the 
donor is an on-site donor or in another hospital. 

In the past, transplantation of the lungs have produced the most 
dismal results of any kind of organ transplantation. Of 38 unilater- 
al lung transplants, no patient lived as long as 10 months, and 
most patients died within a few days to a few weeks after the pro- 
cedure. Presently at Stanford, 8 of 11 patients having transplanta- 
tion of both lungs along with the heart are alive and well, out of 
the hospital and fully rehabilitated 2 months to 2 years after the 
transplant. This complete turnaround in clinical results derives 
from the concept of using the heart as the monitor of immunologic 
events surrounding the transplanted cardiopulmonary axis. Actual 
biopsy of the heart reveals precisely the status of the lungs with 
respect to the host's immune reactivity, since the heart and lungs 
are rejected pari passus. 

Irrespective of any conceivable advance in artificial organs, 
heart-lung transplantation is here to stay. The concept of a totally 
implantable artificial heart with an inexhaustible, noiseless, non- 
heat-producing energy source is one that we all respect, but its re- 
alization is decades away. And anything man-made that could sub- 
stitute for the entire cardiopulmonary axis is simply beyond con- 
ceptualization. The early clinical results of heart-lung transplanta- 
tion at Stanford are so gratifying that other centers are almost cer- 
tain to develop their own programs. Twenty-one such transplants 
have now been done worldwide, and next year we will see perhaps 
another fifty. 

California has a State law that declares the individual dead if 
the brain is dead. The law wisely does not attempt to define brain 
death, but it does consider the difference between brain injury, 
even severe injury, and brain death. There are in use sophisticated 
techniques for maintaining the function of other vital organs in 
brain-dead individuals for extended periods of time. 

At the University of California in San Francisco recently, a 27- 
year-old brain-dead pregnant woman was maintained on a ventila- 
tor with intravenous feedings for 2 months, with the delivery of a 
3-pound, 31 weeks gestation live baby; life after death, as it were. 
This remarkable case illustrates prolonged survival of the heart 
and lungs in a brain-dead patient when appropriate care is given to 
protect those organs from infection, atelectasis or collapse of the 
lungs, and undue loss of circulatory volume. 

At the outset of heart transplantation, many potential heart 
donors were lost owing to medical and nursing neglect. Why put so 
much effort into the care of patients who were already dead? 
Through various educational programs and seminars where the re- 
sults of transplantation of the heard and of the kidneys were dis- 
cussed, intensive care units in most hospitals began to make the 
necessary maneuvers to keep organs in transplantable condition. 
The heart is the most prodigious consumer of oxygen of any organ 
in the body, so its care in the potential donor must be precise and 
thorough. Lungs are even more difficult to maintain in transplant- 
able health. Teaching programs are now just starting in the San 
Francisco Bay area to acquaint intensive unit personnel in certain 
key hospitals with the essentials of pulmonary care in the potential 
heart-lung donor. 



59 

With respect to donors, there are, of course, certain age restric- 
tions. The youngest donor to be used for heart transplantation at 
Stanford was 12 years, the oldest 51. Arteriograms are needed in 
any donor greater than 35 years of age to rule out coronary artery 
disease. In the State of California alone, there are 5,000 traffic 
deaths each year. Not all or even a third of these are suitable for 
donors, but the point is there are many more donors than are now 
being utilized. 

The public is, however, increasingly aware of the possibilities of 
organ donation. In California, there are many renal transplant pro- 
grams, and we collaborate with these centers to an extent that the 
usual wait for a heart is no more than a few weeks. The delay for 
an adequate heart-lung donor is much longer, but we hope to im- 
prove the situation by our outreach training programs for intensive 
care unit personnel. 

In summary, then, transplantation of the heart is a proven 
therapeutic intervention with a 5-year survival of at least 50 per- 
cent, and 1-year survival rate that approaches 80 percent. Physi- 
cians taking care of brain-dead individuals and the families of 
brain-dead patients are becoming increasingly aware of the need 
for transplantable organs. Additional programs are being inaugu- 
rated to train health care personnel in the maintenance of various 
organs in transplantable condition. 

While there may be some future application for the artificial 
heart as an interim device before transplantation, there is no such 
mechanical substitute for the lungs, and the early results of trans- 
plantation of the heart along with both lungs are even better than 
for transplantation of the heart alone. So it is clear that the need 
for adequate identification and care of donors is of tremendous and 
ever-increasing importance. 

Thank you. 

Mr. Gore. Thank you very much, Dr. Shumway. 

We will hold up on questions until the whole panel has complet- 
ed its testimony. 

[The prepared statement of Dr. Shumway follows:] 



60 



HEART AND HEART-LUNG TRANSPLANTATION 

Norman E. Siwnmz* M&\ PhD 

Professor and Chairman, Department of Cardiovascular Surgery 

Stanford University School of Medicine 

Stanford, California 

FIRST, LET ME MAKE A FEW GENERAL COMMENTS REGARDING THE PRESENT 
STATUS OF HEART AND HEART-LUNG TRANSPLANTATION. I WOULD LIKE THEN TO 
FOCUS ON THE SOMEWHAT SPECIAL PROBLEMS ASSOCIATED WITH HEART AND HEART- 
LUNG DONORS. 

DURING THE LAST DECADE TREMENDOUS PROGRESS HAS BEEN MADE IN THE 
SCIENCE AND PRACTICE OF TRANSPLANTATION. NEW DRUGS HAVE BECOME 
AVAILABLE TO CONTROL MORE EFFECTIVELY THE IMMUNE RESPONSE TO 
TRANSPLANTED TISSUE. AS A MATTER OF FACT, SINCE WE BEGAN THE USE OF 
CYCLOSPORIN A IN DECEMBER OF 1980, THERE HAS NOT BEEN A SINGLE INSTANCE 
OF CLINICALLY DIAGNOSABLE REJECTION OF THE ALLOGRAFTED HEART. TRUE, 
THERE ARE SOME DELETERIOUS SIDE EFFECTS OF CYCLOSPORIN A, PRINCIPALLY 
RELATED TO KIDNEY FUNCTION, BUT THE DRUG CAN NOW BE SYNTHESIZED, AND ITS 
NEPHROTOXIC PROPERTIES SHOULD SOON BE DELETED FROM SISTER COMPOUNDS. 

THE DEVELOPING TECHNOLOGY FOR ORGAN PRESERVATION HAS WIDENED THE 
POOL OF DONORS. HEARTS CAN NOW BE TRANSPORTED PROBABLY UP TO 2000 MILES 
WITH EVERY EXPECTATION THAT THE TRANSPLANT WILL PERFORM SATISFACTORILY 
IMMEDIATELY. FURTHER WORK IS PROGRESSING NICELY IN THIS AREA OF 
RESEARCH, AND THE DAY WILL COME WHEN HEARTS CAN BE PRESERVED TO THE SAME 
TEMPORAL LIMITS ENJOYED BY RENAL AND LIVER GRAFTS. 

LAST YEAR IN THE UNITED STATES ALONE APPROXIMATELY 100 PATIENTS 
UNDERWENT CARDIAC TRANSPLANTATION, 30 AT STANFORD. THE ONE-YEAR 
SURVIVAL RATE NOW STANDS AT 80 PERCENT, AND FULLY 90 PERCENT OF ALL 
PATIENTS HAVING HEART TRANSPLANTATION AT STANFORD LEAVE THE HOSPITAL IN 



61 



STABLE CONDITION. THIS STATISTIC CONTRASTS MARKEDLY WITH THE 22 PERCENT 
ONE-YEAR SURVIVAL 15 YEARS AGO, THE FIRST YEAR OF CLINICAL HEART 
TRANSPLANTATION AT STANFORD UNIVERSITY. 

ONE HUNDRED AND SIX OF 260 PATIENTS HAVING CARDIAC TRANSPLANTS AT 
STANFORD ARE ALIVE AND WELL BETWEEN 13-1/2 YEARS AND TWO WEEKS FOLLOWING 
THE PROCEDURE. SUFFICE IT TO SAY THAT TRANSPLANTATION OF THE HEART IS 
NOW ON THE SAME THERAPEUTIC FOOTING AS KIDNEY TRANSPLANTATION. MEDICAL 
CENTERS ALL OVER THE WORLD ARE REENTERING THE FIELD, AND MANY CLINICS 
ARE PRODUCING RESULTS COMPARABLE TO OUR OWN. THIS YEAR THE NUMBER OF 
TRANSPLANTS SHOULD AT LEAST DOUBLE LAST YEAR'S TOTAL WITH FURTHER 
EXPANSION TO BE EXPECTED LATER IN THE DECADE. 

THE HOSPITAL COST FOR A PATIENT HAVING HEART TRANSPLANTATION AT 
STANFORD IS ROUGHLY TWICE THAT FOR A STANDARD OPEN HEART SURGICAL 
PROCEDURE AT STANFORD. NO PROFESSIONAL FEES HAVE EVER BEEN CHARGED FOR 
ANY TRANSPLANTATION PROCEDURE, EITHER HEART OR HEART-LUNG. DONOR COSTS 
AVERAGE $3000 AND ARE INDEPENDENT OF WHETHER THE DONOR IS AN ON-SITE 
DONOR OR IN ANOTHER HOSPITAL. 

IN THE PAST, TRANSPLANTATION OF THE LUNGS, OF PULMONARY TISSUE, HAS 
PRODUCED THE MOST DISMAL RESULTS OF ANY KIND OF ORGAN TRANSPLANTATION. 
OF 38 UNILATERAL LUNG TRANSPLANTS NO PATIENT LIVED AS LONG AS TEN 
MONTHS, AND MOST PATIENTS DIED WITHIN A FEW DAYS TO A FEW WEEKS AFTER 
THE PROCEDURE. PRESENTLY AT STANFORD EIGHT OF ELEVEN PATIENTS HAVING 
TRANSPLANTATION OF BOTH LUNGS ALONG WITH THE HEART ARE ALIVE AND WELL, 
OUT OF THE HOSPITAL AND FULLY REHABILITATED TWO MONTHS TO TWO YEARS 
AFTER THE TRANSPLANT. THIS COMPLETE TURNAROUND IN CLINICAL RESULTS 
DERIVES FROM THE CONCEPT OF USING THE HEART AS THE MONITOR OF 
IMMUNOLOGIC EVENTS SURROUNDING THE TRANSPLANTED CARDIOPULMONARY AXIS. 



23-029 0-83-5 



62 



ACTUAL BIOPSY OF THE HEART REVEALS PRECISELY THE STATUS OF THE LUNGS 
WITH RESPECT TO THE HOST'S IMMUNE REACTIVITY, SINCE THE HEART AND LUNGS 
ARE REJECTED PARI PASSUS. 

IRRESPECTIVE OF ANY CONCEIVABLE ADVANCE IN ARTIFICIAL ORGANS, 
HEART-LUNG TRANSPLANTATION IS HERE TO STAY. THE CONCEPT OF A TOTALLY 
IMPLANTABLE ARTIFICIAL HEART WITH AN INEXHAUSTIBLE, NOISELESS, NON-HEAT- 
PRODUCING ENERGY SOURCE IS ONE THAT MUST BE RESPECTED, BUT ITS 
REALIZATION IS DECADES AWAY. AND ANYTHING MAN-MADE THAT COULD 
SUBSTITUTE FOR THE ENTIRE CARDIOPULMONARY AXIS IS SIMPLY BEYOND 
CONCEPTUALIZATION. THE EARLY CLINICAL RESULTS OF HEART-LUNG 
TRANSPLANTATION AT STANFORD ARE SO GRATIFYING THAT OTHER CENTERS ARE 
ALMOST CERTAIN TO DEVELOP THEIR OWN PROGRAMS. TWENTY SUCH TRANSPLANTS 
HAVE NOW BEEN DONE WORLDWIDE, AND NEXT YEAR WILL SEE PERHAPS ANOTHER 
FIFTY. 

CALIFORNIA HAS A STATE LAW THAT DECLARES THE INDIVIDUAL DEAD IF THE 
BRAIN IS DEAD. THE LAW WISELY DOES NOT ATTEMPT TO DEFINE BRAIN DEATH, 
BUT IT DOES CONSIDER THE DIFFERENCE BETWEEN BRAIN INJURY, EVEN SEVERE 
INJURY, AND BRAIN DEATH. THERE ARE IN USE SOPHISTICATED TECHNIQUES FOR 
MAINTAINING THE FUNCTION OF OTHER VITAL ORGANS IN BRAIN-DEAD INDIVIDUALS 
FOR EXTENDED PERIODS OF TIME. ONE MIGHT IN POINT OF FACT ALMOST CONTEND 
THAT THE DEFINITION OF DEATH TODAY MUST BE MADE IN TERMS OF AN ORGAN 
SYSTEM THAT CANNOT BE TRANSPLANTED, I.E., THE CENTRAL NERVOUS SYSTEM. 
OF COURSE PSYCHIATRISTS MIGHT TELL YOU THEY HAVE BEEN TRANSPLANTING THE 
BRAIN EVER SINCE THE DAYS OF SIGMUND FREUD! AT THE UNIVERSITY OF 
CALIFORNIA -HOSPITAL IN SAN FRANCISCO RECENTLY, A 27-YEAR-OLD BRAIN-DEAD 
PREGNANT WOMAN WAS MAINTAINED ON A VENTILATOR WITH PARENTERAL OR 
INTRAVENOUS FEEDINGS FOR TWO MONTHS, WITH THE DELIVERY OF A 3-POUND, 31 
WEEKS GESTATION LIVE BABY; LIFE AFTER DEATH, AS IT WERE. THIS 



63 



REMARKABLE CASE ILLUSTRATES PROLONGED SURVIVAL OF THE HEART AND LUNGS IN 
A BRAIN-DEAD PATIENT WHEN APPROPRIATE CARE IS GIVEN TO PROTECT THOSE 
ORGANS FROM INFECTION, ATELECTASIS OR COLLAPSE OF THE LUNGS, AND UNDUE 
LOSS OF CIRCULATORY VOLUME. 

AT THE OUTSET OF HEART TRANSPLANTATION, MANY POTENTIAL HEART DONORS 
WERE LOST OWING TO MEDICAL AND NURSING NEGLECT. WHY PUT SO MUCH EFFORT 
INTO THE CARE OF PATIENTS WHO WERE ALREADY DEAD? THROUGH VARIOUS 
EDUCATIONAL PROGRAMS AND SEMINARS WHERE THE RESULTS OF TRANSPLANTATION 
OF THE HEART, AND OF KIDNEYS TOO, WERE DISCUSSED, INTENSIVE CARE UNITS 
IN MOST HOSPITALS BEGAN TO MAKE THE NECESSARY MANEUVERS TO KEEP ORGANS 
IN TRANSPLANTABLE CONDITION. THE HEART IS THE MOST PRODIGIOUS CONSUMER 
OF OXYGEN OF ANY ORGAN IN THE BODY, SO ITS CARE IN THE POTENTIAL DONOR 
MUST BE PRECISE AND THOROUGH. LUNGS ARE EVEN MORE DIFFICULT TO MAINTAIN 
IN TRANSPLANTABLE HEALTH. TEACHING PROGRAMS ARE NOW JUST STARTING IN 
THE SAN FRANCISCO BAY AREA TO ACQUAINT INTENSIVE CARE UNIT PERSONNEL IN 
CERTAIN KEY HOSPITALS WITH THE ESSENTIALS OF PULMONARY CARE IN THE 
POTENTIAL HEART-LUNG DONOR. 

WITH RESPECT TO DONORS THERE ARE OF COURSE CERTAIN AGE 
RESTRICTIONS. THE YOUNGEST DONOR TO BE USED FOR HEART TRANSPLANTATION 
AT STANFORD WAS 12 YEARS OLD, THE OLDEST 51. ARTERIOGRAMS ARE NEEDED IN 
ANY DONOR GREATER THAN 35 YEARS OF AGE TO RULE OUT CORONARY ARTERY 
DISEASE. IN THE STATE. OF CALIFORNIA ALONE THERE ARE 5,000 TRAFFIC 
DEATHS EACH YEAR. NOT ALL OR EVEN A THIRD ARE SUITABLE FOR DONORS, BUT 
THE POINT IS THERE ARE MANY DONORS THAT ARE NOT NOW BEING UTILIZED. 

THE PUBLIC IS, HOWEVER, INCREASINGLY AWARE OF THE POSSIBILITIES OF 
ORGAN DONATION. IN CALIFORNIA THERE ARE MANY RENAL TRANSPLANT PROGRAMS, 
AND WE COLLABORATE WITH THESE CENTERS TO AN EXTENT THAT THE USUAL WAIT 



64 



FOR A HEART IS NO MORE THAN A FEW WEEKS. THE DELAY FOR AN ADEQUATE 
HEART-LUNG DONOR IS MUCH LONGER, BUT WE HOPE TO IMPROVE THE SITUATION BY 
OUR OUTREACH TRAINING PROGRAMS FOR INTENSIVE CARE UNIT PERSONNEL. 

IN SUMMARY, THEN, TRANSPLANTATION OF THE HEART IS A PROVEN 
THERAPEUTIC INTERVENTION WITH A FIVE-YEAR SURVIVAL OF AT LEAST 50% AND A 
ONE <:AK SURVIVAL THAT APPROACHES 80%. PHYSICIANS TAKING CARE OF BRAIN- 
DEAD INDIVIDUALS AND THE FAMILIES OF BRAIN-DEAD PATIENTS ARE BECOMING 
INCREASINGLY AWARE OF THE NEED FOR TRANSPLANTABLE ORGANS. ADDITIONAL 
PROGRAMS ARE BEING INAUGURATED TO TRAIN HEALTH CARE PERSONNEL IN THE 
MAINTENANCE OF VARIOUS ORGANS IN TRANSPLANTABLE CONDITION. 

WHILE THERE MAY BE SOME FUTURE APPLICATION FOR THE ARTIFICIAL HEART 
AS AN INTERIM DEVICE BEFORE TRANSPLANTATION, THERE IS NO SUCH MECHANICAL 
SUBSTITUTE FOR THE LUNGS, AND THE EARLY RESULTS OF TRANSPLANTATION OF 
THE HEART ALONG WITH BOTH LUNGS ARE EVEN BETTER THAN FOR TRANSPLANTATION 
OF THE HEART ALONE, SO IT IS CLEAR THAT THE NEED FOR ADEQUATE 
IDENTIFICATION AND CARE OF DONORS IS OF TREMENDOUS AND INCREASING 
IMPORTANCE. 



65 

Mr. Gore. Dr. Starzl, I have already told you how much we ap- 
preciate your being here. It really is an honor. Please proceed with 
your testimony. 

Dr. Starzl. Thank you, Mr. Gore. 

I provided to the subcommittee copies of a written statement 
which I won't read because I might fall asleep. What it really did 
was to provide a summary for you of the developments in trans- 
plantation, what has made this field possible, and it has really em- 
phasized the kidney, which is the organ that has permitted the de- 
velopment of the antirejection programs. 

I was saddened to hear from Mr. Skeen of somebody who died in 
1962, because that was the year when the great explosion occurred 
with first use of Imuran and Prednisone together. And then the 
subsequent landmarks have been 1966, which is the year that 
triple drug therapy with antilymphocyte globulin [ALG] was intro- 
duced in which ALG plus the other two agents was given in triple 
drug therapy, and then, recently, as you heard, the cyclosporine- 
steroid story. 

Liver transplantation was first carried out, to answer a question 
that you posed before, Congresswoman Schneider, in 1963, almost 
exactly 20 years ago, the 1st of March. It is a procedure that has 
prolonged life for many people, going back a number of years. The 
oldest survival now is in the 14th postoperative year. I was a little 
surprised this morning to see a young handsome teenage boy down 
there, that redheaded boy at the end, who was treated 9 years ago 
last Thanksgiving day. He broke up all of the Thanksgiving parties 
going on. 

Just as a parenthetical aside, you can't control the supply of 
donors. I am sure Dr. Shumway has had the same experience. We 
did Danny — who is from the Washington area — and then followed 
him immediately with a young woman from San Francisco who has 
subsequently had two children and who was sponsored by CHAM- 
PUS. CHAMPUS paid for this procedure. By the way, the San 
Francisco lady, the CHAMPUS symbol, is still living and still per- 
fectly well. I think she is pregnant for the third time. Maybe that 
is what induced them — CHAMPUS — to stop, I don't know. * 

There are surgeons around the country, and many of them — Jim 
Williams, whom you heard already, is a good example — who are 
fully qualified to carry out liver transplantation. In fact, the Ten- 
nessee group is an unusually good one because there are three 
people down there who trained with us. One, many years ago, is 
Lou Britt. Tom Peters spent 1 Vz years with us a few years ago. And 
then there was Jim Williams, whom you heard today. 

But why haven't they been able to function? The reason has been 
this very problem of financing the cost of the enterprise. This is 
really a big tragedy, because we have well-trained people capable 
of carrying out liver transplantations all over the United States 
who can't move forward. In fact, the people whom I have trained 
have been able to function better and in the Far East and Europe 
than they have in the United States. 

I would like to look at the question of cost. It was an outrage to 
Captain Broderick that a price tag should be put on his daughter. I 
would like to look at the situation a little bit differently for those 
who are only interested in money. Captain Broderick's child is in 



66 

the water. If he went into the sea and his rescue would cost $1 mil- 
lion—we do it readily. He can't understand why his daughter who 
is down can't be bailed out. But for those who don't believe that 
kind of sentimental approach, there are studies out— one of them is 
in process at the NIH which shows how much it costs to die from 
end-stage liver disease. 

I spoke to one of the officials at the NIH, whose name I think I 
shouldn't disclose publicly because it would be a breech of confi- 
dence, who told me that, to survive for 1 year after the first hem- 
morrhage from esophogeal varices — which is one of the things that 
happen to people with end-stage liver disease— the cost of survival 
for insurance carriers or for the Government, or for whoever is 
paying that bill, is $260,000, five times as much as a transplant. 

In the American Journal of Surgery, in early 1981, there was a 
study from Boston indicating that the cost of taking care of a pa- 
tient who has bled the first time from an esophageal varix is 
$57,000 if any kind of operation is needed. That is $57,000 down a 
therapeutic cul-de-sac, because patients like that have no place to 
go except the grave. The point is that it costs a lot to bury them, 
far more — and perhaps as much as five times more— as it would 
cost to save them. 

What we are really getting to, I think, to crib a phrase that you 
already used, we don't have the mechanisms of action in place. Jim 
Williams, and perhaps some of the other people, with understanda- 
ble bitterness have described how a ruling — not law — but some 
kind of a guideline ruling by the medicare agency that liver trans- 
plantation is experimental has been used as a refuge by cost-con- 
scious HMO's and apparently by other Government agencies such 
as CHAMPUS to avoid this responsibility. I think you are perfectly 
correct in saying that there is powerful action being taken by the 
White House to try to do something about that, as well as by 
people in legislative bodies of both parties, to try to do something 
about that situation. 

Incidentally, I know for a fact that the same thing applies to car- 
diac transplantation. The field has been distorted, or at least 
caused to remain atrophic, because the same mechanism of denial 
of payments for heart transplants has been used, it is experimen- 
tal. That means that all of the Federal agencies deny payment on 
those grounds. But the real problem comes when the cost-conscious 
HMO's, the third-party private carriers say, "Well, look, the gov- 
ernment has said it is experimental and we will not will not pay 
because, if the Government says so, that must be so." 

Mr. Gore. Dr. Starzl, let me interrupt you to say that it could be 
changed administratively by the White House and by the adminis- 
trators of these agencies. I might note for the record that, when we 
started calling witnesses for this hearing, not long afterwards, we 
heard back from NIH that they were going to schedule in June a 
National Institutes of Health consensus development conference to 
try to change this. 

I think we have a bioethical imperative to change it even before 
then. For patients in the condition of Captain Broderick's daughter, 
we shouldn't have to wait for a conference 2 months from now. She 
may not make it that long. 

Excuse me for interrupting. 



67 

Dr. Starzl. I am glad you did. I think it is important. 

People from all levels and from many agencies have been really 
anxious to have the consensus development conference go forward. 
I am personally anxious to have one go forward for hearts. I was 
with your people, as you know, Norm Shumway, on that white 
paper conference that developed a position in 1980, which actually 
almost had the opposite effect of what we had hoped. It almost stul- 
tified the growth of cardiac transplantation instead of helping it. 

So I think this other avenue, which is really an effort to assure 
third-party insurance carriers that this is a service, is probably a 
better one rather than depending on government funding. 

But the point that I was trying to make is that well-meaning 
people in government can sometimes be the means by which a 
shield, is created which prevents other private agencies from 
taking up the burden. 

The same thing applies to organ procurement. That is the point 
that I really want to get to. As I am sure you will verify, there is 
no visible means of support to get extra-renal organs. There is no 
way to pay for hearts. There is no way to pay for livers. There is no 
way to pay for pancreases or heart-lungs. 

What we have done — and because some of us, Mel Williams and 
I, have been in the kidney field for 20 years — is to call back old 
debts from many people and to develop networks, professional net- 
works, just talking amongst ourselves and we have been able to en- 
graft our efforts upon existing renal programs which are funded 
from Federal sources. 

Here, also, there can be the stultifying effect of Government, be- 
cause — and I think I got this information from Mel Williams about 
a year ago, there was a letter sent or some kind of a for-your-infor- 
mation document sent out from Aetna, which is the carrier for the 
end-stage renal procurement program. It was a kind of a warning 
to the transplant coordinators and to the renal transplant surgeons 
who were out getting organs. It had some flash phrases, including 
the fact that they had to understand that if they collaborated with 
Norm Shumway and with me and others, there was no liability 
coverage, for these extra-renal organs. And second, that they were 
not covered for the expenses of the other organs. 

There was another thing, too, that was very important. I think it 
says something about the courage of the transplant coordinators, 
whom you will be hearing from. They lost their personal liability 
coverage. So as they ran around the country in small planes, if 
something happened to them in the course of going out for livers or 
hearts, they were not covered. This was all stated in the document 
that went around. It really had a chilling effect on the transplant 
coordinators. 

Mr. Gore. Dr. Starzl, without objection, I would like to put that 
document to which you refer in the record at this point. 

I would like to clarify the record that, when you refer to extra- 
renal organs and the problem you are discussing, you are talking 
about a situation where kidneys are harvested from a donor, and 
the other organs such as the heart, the liver, and the lungs, are not 
retrieved for those who need them sometimes because there is no 
funding mechanism for that retrieval. 



68 

Dr. Starzl. Or because there is resistance from people who fear 
the consequences. 

Mr. Gore. Including the lack of insurance and the warning from 
the carrier of the national kidney program that they will lose their 
insurance coverage if they retrieve other organs in addition to the 
kidney. 

Dr. Starzl. There was a such a document, yes. I think that is an 
accurate summary. We can easily get that for you. 

Mr. Gore. It is in the record at this point. 

[The information follows:] 



69 




medicare 
bulletin 

OP-81-6 --- October 1, 1981 



PRODUCT LIABILITY AND 
MALPRACTICE COVERAGE 



PRIMARY INTEREST: ORGAN PROCUREMENT AGENCIES 

In June of this year Aetna informed all IOPAs by letter of 
a potentially serious problem concerning the procurement of 
organs other than kidneys. Our concern was with the costs 
of a lawsuit which originated from the OPA's involvement in 
procuring organs other than kidneys. Hopefully, you have 
reviewed your specific situation with your Board of Dir- 
ectors, Attorney, and Insurance Agent. 

The Health Care Financing Administration - End Stage Renal 
Disease has given us a policy decision on this issue. The 
following paragraphs are their reply. 

If the OPA has product liability and malpractice coverage 
the Medicare Program will reimburse the cost of this insur- 
ance. If you are named a party to a lawsuit which resulted 
from the retrieval of tissue or an organ other than a 
kidney the costs of legal fees, settlements and related 
costs would not be reimbursed by Medicare. 

If the OPA does not have product liability and malpractice 
coverage the Medicare Program will reimburse the OPA for 
legal fees, settlements and related costs for claims 
arising from the retrieval of kidneys. This does not 
include physician professional coverage for the procurement 
of the kidney. However, should a lawsuit develop from 
activity performed in the retrieval of any tissue or organ 
that is not a kidney, the Medicare. Program will reimburse 
none or these expenses. 



Continued on the back 



MR-68526 



LIFE 8. CASUALTY 



70 



Therefore, if you have not already done so, we recommend 
that you evaluate the possibility of these events taking 
place with your Board of Directors, Attorney and Insurance 
Agent. The range of options are: 

1. After your evaluation you believe the risk to be 
minimal and continue to retrieve other organs without 
coverage . 

2. You obtain product liability and malpractice coverage 
for all organs and tissue. 

3. You obtain an agreement with the other organization 
(eye bank, skin bank, etc.) to assume the potential 
liability. 

4. You cease providing any services related to other 
organs . 

5. A variation of the above. 

If we can be of assistance please contact Aetna at (203) 
273-3999. 



TA/tp 

/Etna Life Insurance Company 
Medicare Administration - M101 



71 

Dr. Starzl. I think that the reason that things have gone for- 
ward as they have— and I am sure that Norm Shumway will verify 
this as well— the reason that things went forward is that kidney 
transplanters who have a big network, and maybe especially the 
transplant coordinators, made this a crusade. The transplant coor- 
dinators have discussed it at their meetings. They have asked me 
and others, and we have willingly gone to participate, in their na- 
tional meetings and to tell them how we can put aside some of 
these objections to the procurement of extra-renal organs. 

As a matter of fact, as you have heard from the coordinator, Mr. 
Hall, from Tennessee, they — the coordinators — have themselves set 
up this 24-Donor System which is an 800 number. This donor that 
you heard about this morning came from that 800 system. Mr. Don 
Denny, whom you will be talking to later, set up the 24-Donor 
System. It is the most effective system that I know of. It covers the 
country. 

Solutions— I think if the barriers were removed that are imposed 
by the existing guidelines, it would be an enormous step forward. I 
think we ought to face squarely the fact that this is a new epoc. 
What you said this morning, Norm, and what we have both said in 
print, is that the decade of the 1980's is going to be remembered, I 
think, as the time when transplantation really came to full fruition 
and realizes the promise that did not materialize in the 1960's 
when we all started in transplantation. 

If we recognize that and if we remove these guideline barriers to 
the implementation of programs— the programs will spring up. I 
think there will be many liver programs if this consensus confer- 
ence goes forward positively, and I am guessing 20 to 30. We are 
very busy training people, or refreshing people who are already 
trained, so that they can set up programs. I won't embarrass the 
centers by mentioning their names, but there must be already 
around 12 that are ready to go. 

We have to carry out intensive education efforts, and we are 
really trying to do that through journals. I think we have to reach 
the physicians. Mr. Denny wrote, at their request, an editorial 
about pediatric donor procurement for the Journal of Pediatrics 
which will be coming out soon. But maybe especially we have to 
educate lay people. 

The figures that we have heard about, the low percentage of do- 
nations amongst the black population— it is tragic if it is true. As 
we heard last week at another meeting, the incidence of renal dis- 
ease amongst the black population is higher, not lower, than in the 
population in general, so there is a greater need for organs, not 
less. Thus, there should be a stronger incentive than normal to 
create attractive donor programs amongst blacks. 

The 24-Donor System which I have mentioned, may not be the 
final prototype, but it is a good prototype to start from because it 
just started on its own in response to need. 

I think to develop some way of bringing the extra-renal organs 
on a level of parity with the kidney is quite important. The kidney 
procurement programs are funded by the end-stage renal disease 
program as a free-standing program and, somehow, it needs to be 
written into law, I think, that other organs are needed and are per- 
haps an even more priceless resource. 



72 

Mr. Gore. Thank you very much, Dr. Starzl. We will hold up on 
questions. 
[The prepared statement of Dr. Starzl follows:] 



73 



TESTIMONY: 
THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT 

Organ transplantation including transplantation of the kid- 
ney has been a realistic possibility only since 1962 when mul- 
tiple agent therapy was first standardized. The first break- 
through was in 1962 with the combined use of two drugs called 
Imuran and Prednisone, to which a third agent called antilyrapho- 
cyte globulin - - or ALG - - was added in 1966. 

Using the double drug or triple drug combinations, accept- 
able results became possible with renal transplantation between 
family members. In contrast, the national average for one-year 
kidney survival after renal transplantation using cadaver donors 
has only been about 50 percent. Even such limited successes have 
depended upon the use of high doses of steroids. The steroids 
have such severe side effects that many centers exclude older- 
patients from consideration for kidney transplantation, and in 
some of the European contries no one over the age of 60 is admit- 
ted for consideration. 

Obviously, the transplantation of other organs including 
those of the GI tract - - the liver, intestine, and pancreas - - 
but also including the heart and lung must be from cadaver don- 
ors. Thus, the same limitations imposed by suboptimal drug 
treatment have inhibited the development of transplantation of 
these other organs, including those of the GI tract. For almost 
20 years, there seemed no way out of the dilemma. The drugs 
being used were, on the one hand, unreliable in preventing rejec- 
tion, and on the other excessively dangerous. 



74 



In 1976, Dr. Jean Borel, a basic scientist working at the 
Sandoz Corporation in Basel, Switzerland, discovered and charac- 
terized a new immunosuppressive drug called cyclosporine. This 
drug was released for limited clinical trial in Britain in 1978, 
and in 1979 it became available in the United States at two cen- 
ters, including ours. 

We realized almost from the outset with cyclosporine that 
prednisone could be used in much smaller quantities than at any 
time in the past, that rejection control was better, and with a 
smaller risk to the patients. 

Even during our learning phase (in 1980) the one - year 
cadaver kidney survival rose to 80 percent. Our subsequent ex- 
perience at the University of Pittsburgh On 1981) resulted in a 
one - year cadaver kidney graft survival of greater that 90 per- 
cent. The patient mortality in the first year of our Pittsburgh 
trials was less than one percent. 

Almost from the beginning of cyclosporine use, many of the 
contraindications to kidney transplantation have been softened so 
that people previously excluded because of advanced age or other 
disease have now been accepted as candidates. 

It was natural to extend this major advance in therapy to 
recipients of other organs. The first trials with liver trans- 
plantations under cyclosporine were begun in early 1980, 3 years 
ago. The one - year liver graft and patients survival was twice 
that achievable in previous times, ranging 65 - 70*. These re- 
sults have been so encouraging that at the Unversity of Pitts- 
burgh liver transplantation is now considered a service as op- 



75 



posed to an experimental procedure. We carried out 82 liver 
transplantations in 1982, almost fo~u'r times the yearly number 
ever previously possible in our nearly 20 years of work in this 
field. In 1983, we expect to do more than 100. 

The cyclosporine - steroid combination has also been used 
since early 1981 both at Stanford University and at the Univers- 
ity of Pittsburgh for heart transplantation. 

The implication of these improvements in drug therapy are 
apt to have a profound effect on health care delivery as this 
applies to transplantation. In renal transplantation, the inter- 
face between dialysis and transplantation will be drastically 
altered when cyclosporine becomes generally available, and this 
with a great cost savings to the tax payers who pay for the $2 
billion a year end - stage renal disease program. 

The wider application of transplantation techniques to peo- 
ple with failure of the liver, heart, pancreas, intestine, and 
other organs is a clinical reality today and now. It is likely 
that cost savings can be engendered here also as well as provi- 
sion of better health care. These developments will be dependent 
on improvements of cadaveric organ procurement. 



76 



0270-9139/82/O2O5-0614$O2.0O/0 

Hepatoloc* 

Copyright © 1982 by the American Association for the Study of Liver Diseases 



Vol 2, No 5, pp 614-6.36, 1982 
Printed in USA 



Evolution of Liver Transplantation 

Thomas E. Starzl, Shunzaburo Iwatsuki, David H. Van Thiel, 

J. Carlton Gartner, Basil J. Zitelli, J. Jeffrey Malatack, Robert R. Schade, 

Byers W. Shaw, Jr., Thomas R. Hakala, J. Thomas Rosenthal, and 

Kendrick A. Porter 

Departments of Surgery, Medicine, and Pediatrics, University of Pittsburgh Health Center, 

University of Pittsburgh, Pittsburgh, Pennsylvania 15261 and the Department of Pathology, 

Saint Maiy's Hospital and Medical School, London, England 



Two general kinds of liver transplantation have been 
attempted clinically. With one approach, the host liver is 
removed and replaced with a homograft (orthotopic liver 
transplantation); alternatively, an extra liver is inserted 
at an ectopic site (auxiliary homotransplantation). This 
review concerns only orthotopic liver transplantation. 

The first effort to replace a human liver was made at 
the University of Colorado on March 1, 1963. That pa- 
tient died as did four others during the next 7 months (1, 
2) (Table 1). In September, 1963 and January, 1964, other 
unsuccessful attempts at liver replacement were made in 
Boston (3) and Paris (4) (Table 1). The first clinical trials 
were not frivolously undertaken. Members of the Boston 
and Denver teams had developed techniques for liver 
replacement in dogs in the late 1950s and, in both labo- 
ratories, research on liver transplantation had been con- 
tinuously performed for more than 4 years. 

Nevertheless, the consecutive failures in three institu- 
tions halted all clinical trials until our sixth and seventh 
equally unsuccessful attempts in October, 1966 and May, 
1967. Finally, on July 23, 1967, the first extended survival 
of a human recipient was achieved (5). The patient, a Vh- 
year-old girl, lived for more than 13 months before dying 
of metastases from the hepatocellular carcinoma for 
which she had been treated. From then until the first 
week of May, 1982, we have treated 230 more patients, 
163 at the University of Colorado and 67 at the University 
Health Center of Pittsburgh for a total of 237. The yearly 
frequency of transplantation throughout our experience 
is shown in Figure 1. The highest number of 30 was 
reached in 1981; the number of new cases in 1982 is 
projected at between 60 and 80. 

A signal event in the development of orthotopic liver 



This study was supported by grants from the National Institutes of 
Health (AM 17260, AM-07772, AM-29961, and AM-30183) and from 
the General Clinical Research Centers Program of the Division of 
Research Resources, National Institutes of Health (RR0O051. RR- 
00069, and RR-00084). 

Address reprint requests to: Thomas E. Starzl. M.D., Ph.D., De- 
partment of Surgery, University of Pittsburgh. 1084 Scaife Hall. Pitts- 
burgh, Pennsylvania 15261. 



transplantation occurred on May 2, 1968 when Calne and 
Williams of the University Hospital at Cambridge and 
the King's College in London, respectively, treated the 
first patient in their program (6, 7) which had since 
generated more than 125 well-studied cases. Calne's con- 
tributions in experimental renal transplantation has been 
a major factor in the early development (8) of chemical 
immunosuppression, without which transplantation of 
any organ was not realistic until 2 decades ago. The fact 
that both men had the personal qualities to be able to 
accept defeat or victory with equal grace was fortunate 
since failure was the dominant theme with all such efforts 
until recent times. 

In this review, emphasis will be placed on the more 
than 350 cases in these two series. However, between 
1968 and 1978, other single attempts or small series were 
reported from Boston (9, 10), Los Angeles (11), Montreal 
(12), Bonn (13, 14), Sao Paulo (15), Calgary (16), New 
York City (17), Richmond (18), Minneapolis (19), Man- 
chester (20), and Oslo (21). It is probable that these 
documented cases were a minority of those attempted in 
that decade, exclusive of the English and Colorado series. 
Since 1978, programs have been reopened or started new 
from which important information can be expected. -In 
the United States, clinical liver transplantation programs 
are active at the University of Minnesota (J. S. jNajarian, 
unpublished observations) and the University of Tennes- 
see (J. W. Williams, unpublished observations). Series of 
six or more cases each have been reported or are in 
preparation from Holland (22), East Germany (23), West 
Germany (24, 25), France (26), and the Republic of China 
(H. Q. Hong, unpublished observations). The number of 
cases in the West German series (25) has passed 50, but 
the results have not yet been published in detail. 

EARLY EXPERIMENTAL BACKGROUND 

The first known efforts at experimental orthotopic 
transplantation of the liver were made by Dr. Jack Can- 
non of Los Angeles (27). This report was so brief that it 
lacked a title, description of methods, and notation of the 
animal species. The animals did not survive operation. 



614 



77 



Vol.2. No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



615 



Table 1 The First Trials of Orthotopic Liver Transplantations 



Location 
(ref.) 



Age 

lyrl 



Survival 
(days) 



Main taiise of death 



1 


Denver (1) 


3 


Extrahepatic biliary atresia 





2 


Denver (1) 


48 


Hepatocellular cancer, cirrhosis 


22 


3 


Denver (1) 


68 


Duct cell carcinoma 


IV, 


4 


Denver (2) 


52 


Hepatocellular cancer, cirrhosis 


&A 


5 


Boston (3) 


58 


Metastatic colon carcinoma 


11 


6 


Denver (2) 


29 


Hepatocellular cancer, cirrhosis 


23 


7 


Paris (41 


75 


Metastatic colon carcinoma 






Hemorrhage 

Pulmonary emboli, sepsis 

Sepsis, pulmonary emboli, gastrointestinal 
bleeding 

Pulmonary emboli, ? hepatic failure, pul- 
monary edema 

Pneumonitis, liver abscesses, hepatic failure 

Sepsis, bile peritonitis, hepatic failure 

Hemorrhage 



; j flelransplantation 
I Primary Ortholopic Ttansplanlahon 



n i l l . 



63 64 65 66 67 I 



I 69 70 71 72 73 74 
YEARS 



5 76 77 76 79 80 81 82 



Fig. 1. Yearly number of liver transplantations at the University of 
Colorado (1963 to 1980) and the University of Pittsburgh (1981 to 
1982) Note that retransplantation has been attempted frequently. 



In June, 1958, a program of orthotopic transplantation of 
the canine liver was initiated at the Peter Bent Brigham 
Hospital under the direction of Dr. Frances D. Moore 
(28), and in August, our first experiments in the same 
species were begun at Northwestern University in Chi- 
cago (29, 30). 

The technical problems of liver replacement and the 
features of rejection in untreated canine recipients were 
delineated (28-31). Eventually, using immunosuppres- 
sion with azathioprine (32-34) and antilymphocyte serum 
or its antilymphocyte globulin (ALG) derivative (32, 
35-38), chronic survival was achieved in mongrel dogs of 
which one lived for almost 12 years (39). 

In 1965, Gamier of Paris (40) made the important 
observation that rejection of pig liver homografts was 
mild in comparison to that in dogs. Several porcine 
recipients lived for long times without immunosuppres- 
sion. Workers in Bristol (41), Cambridge (42), and Denver 
(32) promptly confirmed Garnier's work. The value of 
the pig for transplantation research has been demon- 
strated frequently in the investigations of Calne and his 
associates. 

Hundreds of significant experimental studies in various 
species have since been published. Review of this work 



will not be attempted although some of it has influenced 
the clinical trials as will be noted later. 

NOTATIONS ABOUT SURGICAL TECHNIQUES 
IN HUMANS 

A training period in the animal laboratories is an 
important preparatory step for teams planning clinical 
programs; however, not all of the experimental tech- 
niques are identical in humans. Our methods of ortho- 
topic liver transplantation (1, 5, 32, 43-52) and the mod- 
ifications introduced by Calne et al. (6, 47, 53) have been 
described. 

The operation is simple in principle (Figure 2), but its 
execution has been exceptionally difficult because of the 
almost invariable debilitation of the recipients and the 
profoundly abnormal vascularization patterns caused by 
portal hypertension in endstage liver disease. Defects in 
clotting have been present in most cases (1, 32, 54, 55), 
and adhesions or other alterations secondary to previous 
operations are often complicating factors. With such a 
background, it is not surprising that the postoperative 
care of many patients has been an exercise in resuscita- 
tion (32). The most common difficulties have been pul- 
monary insufficiency (requiring mechanical ventilation 
for several months in some cases), renal failure with 
massive fluid shifts, and persistent clotting abnormalities. 
These problems are managed with conventional methods 
of intensive care with emphasis on biochemical and he- 
modynamic monitoring. Recovery can be expected from 
encephalopathy and the hepatorenal syndrome (56). 

The ability to survive this critical period depends upon 
what has transpired in the operating room. Thus, in the 
following remarks, we will touch upon details of surgical 
technique which require reemphasis or points of view 
which have changed from those expressed in the past. 

Organ Procurement and Preservation 

Until 1976, techniques for preserving the liver either 
severely limited the acceptable time of cold ischemia or 
were too complicated for use in outlying hospitals (32). 
In 1976, simple methods that permitted reasonably long 
storage were developed, and clinical trials were started. 
We have employed an electrolyte (Collins) solution with 
a composition similar to that found intracellularly (57). 
The Cambridge-King's College team uses a plasma so- 
lution for similar cold infusion of the homograft (58). In 
dogs, the two methods yielded similar results (57) and 
allowed safe preservation for up to 12 hr These tech- 



78 



316 



STARZL ET AL. 



Hepatolo<;y 





Fig. 2. Completed orthotopic liver transplantation (A) Biliary tract reconstruction with choledochorholedochostomy. (B) Biliary tract 
reconstruction with choledochojejunostomv. using a Roux limb. 



niques permit shipment of livers from city to city. More 
than two-thirds of the livers used in the Pittsburgh 
program have been obtained outside of the normal pro- 
curement area for this region; the longest transit being 
from Phoenix, Ariz. Efficient air travel arrangements are 
necessary; to meet this objective, several Pittsburgh cor- 
porations have donated their private jet airplanes. 

Liver procurement outside of the local area has de- 
pended on cooperation with other procurement centers 
whose main function was previously to provide cadaveric 
kidneys. Fear that kidney grafts would be jeopardized by 
giving too high a priority to the liver has been allayed by 
standardization of techniques which protect all organs 
equally and which can be adapted to the local surgeons' 
wishes (59). 

A midline incision is made from the pubis to the neck, 
and the sternum is split. The structures entering and 
leaving the liver are skeletonized, and the necessary 
preliminary steps for kidney removal are taken in the 
presence of an intact circulation. Then a cannula is 
placed through the splenic vein into the superior mes- 
enteric vein. Rapid infusion of cold lactated Ringers' 
solution is used to start cooling of the liver. After 1 or 2 
liters have been infused, cold Collins solution is infused 
through the terminal aorta at the same time as the distal 
thoracic aorta is cross-clamped and the cadaveric donor 
is exsanguinated from a cannula previously placed in the 
distal inferior vena cava. After removal, the cold liver is 



flushed with Collins solution and protected by a plastic 
bag which is placed in slushed ice. The performance of 
kidneys removed from liver donors with this technique 
was as good or better than has been achieved in most 
centers with kidney removal alone (59). With minor 
modifications, it has also been possible to remove the 
heart in addition to kidneys and liver from seven donors. 
During 1981 when 30 liver homografts were used, there 
were 176 offers of organs. The inability to use the other 
146 livers was usually because there was a disparity in 
size between the donor and recipient, the donor blood 
group was incompatible with the recipient, or Pittsburgh 
facilities for liver recipient care were saturated. An actual 
shortage of pediatric donors has existed in the 1- to 5- 
year age group. 

Recipient Hepatectomy 

The most demanding aspect of liver transplantation is 
removal of the diseased native organ. The technical 
difficulties are usually determined by the underlying 
disease. The easiest situations are in patients with pri- 
mary hepatic malignancies or primary biliary cirrhosis. 
The most difficult are in recipients with the shrunken 
livers of macronodular cirrhosis or in patients with mul- 
tiple previous operations. On the average, hepatectomy 
is easier in infants and children than in adolescents and 
adults. 

The preexisting pathologic changes often necessitate 



79 



Vol. 2. No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



617 



deviations from a standard plan; however, the first step 
is to find the hilum and dearterialize the liver which 
expedites hilar dissection and slows hemorrhage from the 
liver surface. During hilar dissection, the bile duct is 
transected as high as possible so that the option of duct- 
to-duct anastomosis is retained. The portal vein is left 
intact until later, in order not to aggravate the portal 
hypertension. 

The inferior vena cava below the liver is encircled with 
minimal dissection. The left triangular and falciform 
ligaments are incised until the suprahepatic vena cava is 
identified. The suprahepatic vena cava is encircled to 
allow placement of a cross-clamp. 

If all of these maneuvers are successfully executed, the 
liver can be isolated from the circulation by cross-clamp- 
ing vessels which have been encircled but are intact. 
Cuffs of the suprahepatic and infrahepatic vena cava are 
fashioned from these vessels as the liver is removed. 
Sufficient infrahepatic vena cava is not difficult to obtain, 
but development of an adequate suprahepatic cuff may 
require tailoring of the vena cava which is mobilized from 
within the liver (46). The technique of isolating the liver 
and peeling it out in a bloodless state permits all residual 
tissue connections of the right triangular ligament and 
the bare areas (including the right adrenal vein) to be 
ligated under direct vision. The penalty with this ap- 
proach is an increase (usually about 30 min) in the time 
of portal and vena caval cross-clamping, compared to 
cross-clamp time with previously described techniques 
(1,32,43). 

Such cross-clamping is usually tolerated in patients 
with chronic disease in spite of major declines in cardiac 
output and variable hypotension (60): the same thing has 
been demonstrated in dogs subjected to chronic bile duct 
obstruction (61). Because of this, venous bypasses which 
were used in our first cases were discontinued (1, 2). 

Some patients are jeopardized by the venous cross- 
clamping. If severe hypotension occurs after cross-clamp- 
ing, Calne et al. (52, 53) recommend femoral vein-to- 
femoral artery bypass with an intervening oxygenator. 
About 10% of the English patients are so treated. One 
death in our last 67 patients (OT 233, Table 14), as well 
as a cardiac arrest which was successfully treated, may 
have been avoided by this precaution. 

The fact that most patients recover from portal and 
vena inferior caval cross-clamping may have created a 
false impression about the safety of this practice. Usually, 
there is gross swelling of the intestine during the period 
of occlusion. Subsequently, many patients suffer from 
third-space fluid sequestration and postoperative renal 
failure. The extent to which these complex physiologic 
events contribute to the high perioperative mortality has 
not yet been delineated. For this reason, we returned in 
recent cases (not reported in this communication) to the 
practice of venous bypass which had been abandoned. 
Cannulas are placed into the inferior vena cava through 
an iliac or femoral vein and into the portal system 
through the open end of the transected portal vein. 
During the anhepatic phase, the blood is returned to a 
reservoir and pumped to a large vein in the neck or arm. 
Although this kind of bypass requires total body hepar- 



inization, bleeding has not been excessive since the 
"heparin effect" can be effectively reversed even in pa- 
tients with severe liver disease. 

Biliary Tract Reconstruction 

Difficulties with biliary tract reconstruction were fre- 
quently lethal in our experience (43, 62, 63) and in that 
of the English workers (7, 49-51) until the mid-1970s. 
Anatomic studies by Terblanche et al. (64) suggest that 
deficient blood supply of the homograft duct system may 
be a contributory factor; however, our principal problems 
were due to the frequent (and inappropriate) use of 
cholecystoduodenostomy and to failure to diagnose the 
complications. The latter deficiency was resolved with 
the frequent use of postoperative cholangiography (Fig- 
ure 3) and reoperation, if necessary. The incidence of 
complications has been reduced with better primary re- 
construction. 

We now consider duct-to-duct anastomosis to be the 
procedure of choice (Figure 2A). When this is not feasible, 
the duct is anastomosed to a Roux limb of jejunum 
(Figure 2B). With either technique, the homograft gall- 
bladder is removed The results of biliary tract recon- 
struction in the last 67 cases are shown in Table 2. Using 
choledochocholedochostomy or choledochojejunostomy, 
an eventually satisfactory result was obtained in more 
than 95% of cases, although the use of an internal stent 
(instead of a T-tube stent) for duct-to-duct anastomoses 
led to a high rate of reoperation. Only two deaths resulted 
directly from biliary tract reconstruction. 

Since 1976, Calne et al. (48) have used a technique in 
which the homograft common duct and gallbladder are 
fashioned into a common channel and anastomosed to 
recipient common duct or a Roux limb. Waddell and 
Grover (65) had described such a common channel pro- 
cedure for difficult biliary tract problems. 

The Question of Splenectomy 

The spleen was removed in most of our early patients, 
in part to achieve immunodepression, but mainly to 
relieve hypersplenism and leukopenia which prevented 
the effective use of azathioprine or cyclophosphamide 
(32). With the advent of cyclosporin A, splenectomy was 
discontinued. 

Untreatable Complications 

Technical complications that have occurred after liver 
transplantation are legion. All have been potentially 
treatable except for irreversible ischemic injury of the 
graft or early loss of its blood supply. Retransplantation 
is the only hope for a patient who has been given an 
irreversibly damaged or devascularized organ. In one of 
our patients, portal vein stenosis at the anastomosis was 
diagnosed 8 months after transplantation, and, at reop- 
eration, the stenosis was successfully resected in spite of 
the fact that thrombosis had occurred requiring throm- 
bectomy (Figure 4). 

TISSUE MATCHING 

The time constraints of liver preservation and urgent 
recipient need usually preclude systematic efforts at tis- 



80 



618 



STARZL ET AL. 



Hepatology 




Fig. 3. Biliary obstruction 8 months 
after liver transplantation and a duct-to- 
duct reconstruction in a 10-year-old 
child. Note the ectasia of the recipient 
common duct {arrow). At reoperation, 
the graft common duct was anastomosed 
to a Roux limb of jejunum with a good 
result. 



sue matching. With the random donor-recipient pairing, 
good matches at the A, B, and DR loci have never been 
obtained. 

Hepatic transplantation has been performed (45, 50, 
51, 66) against the recipient anti-donor T-warm anti- 
bodies which cause hyperacute rejection of kidney hom- 
ografts. To our knowledge, hyperacute rejection of the 
liver has never been seen. 

However, much more experience will be required be- 
fore concluding that acceptance of "positive cross- 
matches" against T-warm recipient antibodies is without 
jeopardy. Data from the first 53 Pittsburgh cases is 
summarized in Table 3. Patients for whom cross-matches 
could not be performed or whose sera cross-matched 
negative with recipient cells had better results than those 
with cross-match positive donors. Although hyperacute 
rejection was not observed in the latter recipients, the 



postoperative courses were stormy. At least two of the 
livers developed delayed massive necrosis. 

From experimental studies, it is known that the liver 
is resistant to hyperacute rejection. However, in animal 
xenograft models in which the recipient has performed 
heterospecific cytotoxins, humoral antibody rejection of 
the liver is merely slower than that of the kidney; the 
mechanisms of destruction are the same. The extent (if 
any) to which the outlook after clinical liver transplan- 
tation is depreciated by preformed antibodies is un- 
known; many liver candidates have widely reacting T- 
warm cytotoxic antibodies which reflect sensitization by 
previous blood transfusions. For the time being, we con- 
tinue to treat such highly sensitized patients. 

If donor-recipient ABO blood group incompatibility 
exists, renal grafts can be destroyed by isoagglutinins 
(67). Liver grafts are resistant to this kind of hyperacute 



81 



Vol. 2, No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



619 



Table 2. Primary Bile Duct Procedures and Complications in 75 Liver Transplantations on 67 Consecutive Patients 

in the Cyclosporin Era 



Choledochochole- Choledochochole- Choledochojejunos- 

dochoslomy with dochostomy with tomv in Roux-en Y 

T-tube internal stent with stent 



Cholecvstojejunos- 
tomy in Roux-en-Y 



External tube 
drainage 



Biliary reconstruc- 
tion not completed 
(intraoperative 
death) 



No. 


25 


19 


20 


6 


Success 


20 


11 


18 


1 




(80%) 


. iff . j 


(90%) 


f.17%) 


Failure 


5 


8 


2 


5 


Reoperation required 


4' 


7* 


2 


5 


Cause of death 





1 


1 





Nature of failure 










Obstruction 


1 


3 





4' 


Bile leakage 


4 


4 


2 


1 


Arterioductal fistula 





1 









" Reconstruction was never completed in 2 of the 3 patients. 
6 One patient was treated with transhepatic dilation under X-ray control 
One patient developed a large fungal liver abscess, which led to retransplantation. He is doing well with the second liver graft 1 year later. 




Fig. 4. (a) Stenosis of the portal vein anastomosis yarrow) diagnosed by transhepatic portography in the same patient whose biliary system is 
shown in Fig. 3. lb) Operative venogram obtained through a mesenteric vein a few days later. The obstruction was complete, and the homograft 
portal vein was full of thrombus, (c) Patent system after resection of the sterosis, thrombectomy, and reanastomosis. 



Table 3. Influence of Transplantation against Donor- 
Specific Cytotoxic T-Warm Antibodies (Cyclosporin Era)" 

Survival (months) 



Table 4. Cases of Donor-Recipient Blood Group 

Incompatibility in 53 Consecutive Primary Liver 

Transplantations at the University of Pittsburgh 



>1 



>2 



[m ompatibil- 



F,.irl\ graft function 



i ini. Dine 



Negative cross- 
match 

Positive cross- 
match 

Cross-match not 
done 



31 24 22 

177', i 

8 5 5 

(63%) (63%) 

14 13 in 
(9 ft i 



21 
(68%) 

4 
i.Mr, i 
12 



193 

iy<s 



A— B 
A^ B 



Good 
Good 



Well. 12 months 
Died, systemic aspergil- 
losis, 8 days 



" Data from 53 consecutive primary transplants at the University ,,i 
Pittsburgh. 

rejection (45). In two of our Pittsburgh cases, two incom- 
patible donors were used (Table 4). The course of one of 
these patients is shown in Figure 6. We have tried to 
avoid this practice since blood group compatible donors 
can usually be found. 



IMMUNOSUPPRESSION FOR HUMANS (THE 
KIDNEY TRANSPLANT PROTOTYPE) 

It was important to demonstrate in animals that 
chronic survival is possible after liver transplantation 
under immunosuppression. However, such laboratory in- 
vestigations contributed relatively little to the immuno- 
suppressive regimens which have been used clinically. 
Liver transplantation, either in animals or man, was too 
complex to be used as a model to evaluate drugs or drug 



82 



620 



STARZL ET AL. 



Hepatology 



combinations. Instead, all methods to prevent or reverse 
rejection of whole organs have depended upon observa- 
tions after renal transplantation. 

The immunosuppressive protocols that have been de- 
veloped for human renal transplantation are summarized 
in Table 5, exclusive of the historically important trials 
with total body irradiation (68). Because the first genu- 
inely promising drug, azathioprine (8), proved to be ef- 
fective only rarely when given alone (69), the "modern" 
era was not entered until it was realized that azathioprine 
and prednisone have an additive (or possibly synergistic) 
effect (67, 70-73). At the outset, our policy was to begin 
therapy after renal transplantation with azathioprine and 
to add high doses of prednisone with the first signs of 
rejection (70). Because it was rare to escape rejection 
even after transplantation from closely related donors, 
our recommendation (67) was to begin treatment with 
both drugs immediately after transplantation with a 
gradual reduction in prednisone. Such "double-drug ther- 
apy" has been the most commonly used immunosuppres- 
sion for almost 20 years. 

With transplantation from consanguineous donors un- 
der double-drug treatment, chronic renal graft function 
was achieved almost immediately in more than two- 
thirds of cases. However, during the first year after 
cadaveric renal transplantation, the graft loss rate in 
multicenter compilations remains at about 50% (74, 75). 
Liver recipients for whom cadaveric donors were obliga- 
tory, and who did not have the option of fall-back main- 
tenance on an artificial organ therapy analogous to renal 
dialysis in the event of rejection, were confronted with a 
bleak outlook. 

Between 1963 and 1979, several alternative therapeutic 
programs were introduced for renal transplantation 
(Table 5); all were modifications of or additions to the 
original double-drug therapy. A promising approach in- 
volved lymphoid depletion with ALG (36) which was 
given i.m. or i.v. as an adjunct to azathioprine and pred- 
nisone during the first few weeks or months when the 
risk of rejection is the greatest. "Triple-drug therapy" 
has been the second most commonly used technique of 
immunosuppression. A conceptually important but prag- 
matically inconsequential detail was that cyclophospha- 
mide could be freely substituted for azathioprine (76). 
The results of 1-year graft survival after cadaveric renal 



transplantation under triple-drug therapy were improved 
in most centers. After the discontinuance of ALG, there 
was an unacceptable rate of delayed rejection which, not 
surprisingly, also occurred after liver transplantation 
(32). The alternative of temporary lymphoid depletion 
with thoracic duct drainage (TDD) (77) in preparation 
of patients for cadaveric renal transplantation (78) had 
the same disadvantage (79). Efforts to use preoperative 
TDD in liver recipients usually, created insurmountable 
problems because of the prodigious quantities (as much 
as 2 liters per hr) of thoracic duct lymph which patients 
with hepatic insufficiency produced (80). Lymphoid de- 
pletion by total lymphoid irradiation for conditioning 
before grafting (81, 82) has not been tried in liver recipi- 
ents. 

There was widespread discontent with all techniques 
of immunosuppression from 1963 to 1978. Many kidney 
transplant surgeons attempted to escape the conse- 
quences of this therapeutic cul de sac by exploiting 
developments in tissue typing and matching, or by sys- 
tematically conditioning prospective renal recipients 
with preoperative blood transfusions. The former efforts 
yielded disappointing results after cadaveric kidney 
transplantation; the latter practice of conditioning by 
transfusion allowed an increased success rate in patients 
not accidentally sensitized during their preparation. In 
any event, liver transplantation candidates usually were 
too ill to wait for a well-matched liver or to undergo 
stages of preoperative preparation. For future trials of 
liver transplantation, it was necessary to hope for better 
immunosuppressive drugs. This did not seem realistic 
until the advent of cyclosporin A. 

Cyclosporin A is an extract from the fungi Cylindro- 
carpon lucidum and Trichoderma polysporum. It was 
discovered and characterized biochemically by scientists 
at the Sandoz Corp., Basel, Switzerland. Cyclosporin A 
was shown to be immunosuppressive by Borel et al. (83, 
84) in mice, rats, and guinea pigs. The drug depressed 
humoral and cellular immunity with a preferential and 
quickly reversible action against T-lymphocytes. These 
effects were not accompanied by bone marrow depression 
which frequently limits the doses of azathioprine and 
cyclophosphamide. The unusual effectiveness of cyclo- 
sporin A in preventing or delaying rejection of mouse 
skin homografts was demonstrated by Borel et al. (83, 



Table 5. Clinical Immunosuppressive Drug Regimens Developed with Kidney Transplantation 



Agents 


Year described and re- 
ported 


Place 


Deficiencies ' 


Used for liver 
ransplantation 


Azathioprine 


1962 (69) 


Boston 


Ineffective, dangerous 


No 


Azathioprine — Steroids 


1963 (70-73) 


Denver. Boston, Richmond, 
E din borough 


Suboptimal 


Yes 


Thoracic duct drainage as 


1963 (77)" 


Stockholm 


Nuisance; requires 20-30 days pre 


Yes 


adjunct 






treatment 




ALG as adjunct 


1966 (36) 


Denver 


Still suboptimal 


Yes 


Cyclophosphamide substitute 


1970 (76) 


Denver 


No advantage except for patients 


Yes 


for azathioprine 






with azathioprine toxicity 




Total lymphoid irradiation 


1979 (81, 82) 


Palo Alto, Minneapolis 


Dangerous; extensive preparation; 
not quickly reversible 


No 


Cyclosporin A alone 


1978-1979 (90, 91) 


Cambridge 


Suboptimal 


Yes' 


Cyclosporin A — Steroids 


1980 (92, 93) 


Denver 


Under evaluation 


Yes - 



' It was not realized until much later that pretreatment for 3 to 4 weeks before transplantation was a necessary condition (78). 



83 



Vol 2. No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



621 



84). Analogous observations in which heart, kidney, liver, 
and pancreatic grafts were protected in rats, rabbits, 
dogs, and pigs were reported by Kostakis (85), Calne 
(86-88), and Green (89) and their associates. 

When cyclosporin A was first used in patients by Calne 
and coworkers (90, 91), it was hoped that no other drug 
would be routinely required. Our dissenting opinion is 
that cyclosporin A should be combined with steroid 
therapy from the outset (92, 93). The extent to which 
steroids are required with cyclosporin A remains to be 
clarified, but it is clear that kidney survival of greater 
than 80% can be expected 1 year after primary cadaveric 
transplantation (93, 94). Long-term follow-up of our orig- 
inal recipients and those of Calne has not shown a 
tendency for patients under cyclosporin A to have "catch- 
up" graft losses or unexpected delayed morbidity from 
other causes. We and Calne have not had the disillusion- 
ment reported by Carpenter et al. (95) and Sweny et al. 
(96) in their first trials with cyclosporin A for cadaveric 
renal transplantation. 

As new teams begin using cyclosporin A, it will be 
important to avoid unrealistic expectations about early 
convalescence that could be engendered by the high 
success rates achieved after cadaveric renal transplanta- 
tions. In a recent analysis of 42 consecutive cadaveric 
renal recipients (97), only one-third had a completely 
uneventful recovery. Of the remainder, most developed 
rejection which was usually reversed with augmented 
steroid therapy. In every case, the major differential 
diagnosis was rejection vs. nephrotoxicity from cyclo- 
sporin A. 

Nephrotoxicity of cyclosporin A was first noted by 
Calne (90, 91) and Powles (98), and has been confirmed 
elsewhere (92, 99). To sharpen the interrelationship be- 
tween therapeutic effect and toxicity, pharmacologic (cy- 
closporin A blood and/or plasma levels) and immunologic 
monitoring were advocated by Keown (100), Rynasiewicz 
(101), and Kahan (102). Our techniques of management 
have not depended upon these monitoring techniques. 
Fortunately, nephrotoxicity usually has promptly re- 
versed with reduction of cyclosporin A doses. As a last 
resort, a change from cyclosporin A to azathioprine has 
been made but at an increased risk of rejection (99). 

Most other side effects of cyclosporin A (90-94) are not 
serious and include gingival hyperplasia, tremor, regional 
flushing or vague abdominal discomfort just after drug 
ingestion, and development of brtast fibroadenomas in 
women. Although hepatotoxicity occurs in about one- 
fifth of cases (103), it is rarely serious enough to neces- 
sitate a change to azathioprine. 

The most publicized question about cyclosporin A 
concerns its potential oncogenicity. It has been known 
for 15 years that conventional immunosuppression re- 
sults in an increased incidence of de novo tumors, of 
which approximately one-third are lymphomas (104). 
Early reports by Calne (91) of lymphoma development 
in patients treated with cyclosporin A were not surpris- 
ing, although the incidence of three lymphomas in 34 
recipients was sobering. Calne attributed this high inci- 
dence to the concomitant use of other cytotoxic drugs 
and possibly steroids. In our own experience with cyclos- 
porin A and steroid therapy in almost 200 cadaveric renal 



recipients, there have been two lymphomas. One was an 
incidental finding at autopsy following a fatal infection 
(93). The other was successfully treated by intestinal 
resection after it had caused a perforation (97). To our 
knowledge, no de novo epithelial tumors have been seen 
in renal recipients. As experience with cyclosporin A 
accumulated worldwide, the spectre of this drug being a 
spectacular tumor producer has receded. None of the 
liver recipients treated with cyclosporin A and steroids 
has developed new malignancies. 

IMMUNOSUPPRESSION AND LIVER 
TRANSPLANTATION 

Two patients are known to have been given orthotopic 
liver grafts without immunosuppression or with steroid 
therapy only. The first patient was in the Cambridge 
series (7); the other was treated in Oslo (21). One factor 
in these decisions may have been the demonstration in 
dogs (32, 33) and pigs (32, 40-42) that rejection of liver 
grafts was less severe than that after renal transplanta- 
tion. In addition, the English recipient had hepatitis 
which it was feared would be reactivated by immuno- 
suppression. Both organs promptly failed with early 
death of the patients. 

All other patients were given some variant of the 
double- or triple-drug treatment summarized in Table 5 
Our first five recipients and occasional ones later were 
treated with azathioprine and prednisone. The same 
treatment was used for almost all patients in the Cam- 
bridge series from 1968 through 1979. 

Triple-drug treatment was used in the majority of 
recipients from 1966 through 1979. The most common 
regimen was azathioprine, prednisone, and a variable 
course of i.m. ALG which was begun on the day of 
operation. The duration of ALG was usually limited to a 
few weeks because of sensitization of the recipients to 
horse, rabbit, or goat globulin; however, treatment with 
ALG was continued in some cases for 6 to 12 months. 

In a modification of triple-drug therapy (Table 5), 
cyclophosphamide instead of azathioprine was given to 
16 patients (OT 42-57) from March, 1971 to August, 1972 
(105). Six (37.5%) recipients lived for at least 1 year, and 
four (OT 42, 46, 53, 56) are still alive more than 10 years 
later. From a few months to several years after trans- 
plantation, all surviving patients were switched to aza- 
thioprine. Because the results during this period were 
not markedly different than with the original triple-drug 
management, cyclophosphamide was not further used as 
a first line drug. 

In 1978 and 1979, TDD was used as an adjunct to 
therapy with azathioprine and prednisone in 21 patients 
(80). TDD was started 10 to 18 days before transplanta- 
tion in 2 patients, on the day of operation in 17 patients, 
and 2 and 4 weeks after transplantation in the other two. 
Six (31.6%) of 19 recipients who had TDD started prior 
to or on the day of transplantation lived for at least 1 
year and five are alive after 3% to 4V5 years. The man- 
agement dilemma was that in the kidney transplantation 
model, TDD was ineffective unless applied at least 3 
weeks in advance of transplantation (78), but potential 
liver recipients could not tolerate the chronic, high-vol- 
ume thoracic lymph drainage associated with hepatic 



84 



622 



STARZL ET AL. 



Hepatology 



disease. If TDD is to be tried again in liver transplanta- 
tion, a closed system will be required in which lympho- 
cytes can be removed in transit without the necessity for 
lymph removal and later reinfusion. 

Calne et al. (91) were the first to use cyclosporin A for 
liver transplantation. In their first two cases, cyclosporin 
was used alone. However, most of their experience has 
been with delayed administration of the drug (53, 106). 
Azathioprine (1.5 mg per kg per day) and prednisolone 
(0.4 mg per kg per day) were used until renal and hepatic 
functions were adequate. Then, cyclosporin A (10 mg per 
kg per day) was begun, and the steroid dose was slowly 
reduced to zero. The supervention of acute rejection 
during treatment with azathioprine and prednisone was 
troublesome and, in the last review by Calne et al. (53), 
they recommend shortening this period. 

Our practice (107-109) has been to start cyclosporin A 
a few hours preoperatively with an p.o. dose of 17.5 mg 
per kg (Figures 5 to 7). Cyclosporin A is continued daily, 
but with reduced i.m. or i.v. quantities (Figure 7) until 
p.o. diet is resumed. Subsequently an p.o. dose of 17.5 
mg per kg per day is given, usually with half the daily 
dose every 12 hr. The quantities are reduced subse- 
quently if toxic manifestations develop, of which neph- 
rotoxicity has been the most important (Figures 5 and 
6). Usually, steroids are also started on the day of oper- 
ation. For adult patients who leave the operating room 
in relatively good condition, a 5-day burst of prednisolone 
is given, starting at 200 mg and stopping with a mainte- 
nance dose of 20 mg per day (Figure 5). Further reduc- 
tions of cyclosporin A and steroid doses are made on an 
individualized basis. Initial and maintenance therapy 
with steroids are reduced in infants and children (Fig- 
ure 6). 

If the patient was in poor postoperative condition, the 
initial burst of high-dose steroid therapy was omitted for 



a few days or greatly reduced (Figure 7). A few patients 
suspected of having nephrotoxicity from cyclosporin A 
were switched temporarily to azathioprine with resump- 
tion of cyclosporin A treatment as renal function im- 
proved (Figure 6). With less severe renal impairment 
(Figures 5 and 7), the dose of cyclosporin A was reduced. 
No patient has been changed to azathioprine perma- 
nently. If rejection occun-ed in spite of this therapy, the 
principal responses have been to administer intermit- 
tently large i.v. doses of hydrocortisone (or prednisolone) 
(Figures 5 and 7), repeat the original 5-day burst of 
steroids (Figure 7), and settle at a higher maintenance 
level of steroids. Although cyclosporin A does not permit 
much dose maneuverability, it has sometimes been pos- 
sible to increase the amounts given despite the risk of 
nephrotoxicity. 

REJECTION AND ITS MODIFICATION 
To interpret much of the statistical information to be 
presented later in this review, it will be necessary to 
describe the features of homograft rejection as these have 
been perceived by the pathologist and surgeon. 

The Morphologic Events of Rejection 

Despite treatment with any of the immunosuppressive 
regimens so far used, rejection of human hepatic homo- 
grafts has been observed. A clear picture can be pieced 
together from studies of orthotopic liver transplantation 
in rats, dogs, pigs, baboons, and humans of the sequence 
of pathologic events which occur when a modified or 
unmodified recipient rejects a liver graft (110-113). 

In untreated members of all species (the principal 
observations have been in dogs), there is a quiescent 
phase of at least 2 or 3 days during which only rare small 
lymphocytes are found in the tissue spaces of the liver 



o _. 
tn E 



< E 
>■ c* 
" E 



150 

100 

50 



500 

1000 



47 YEAR OLD 9 
44 kg 




Hllllllllli 



S S « I GRAM HYDROCORTISONE 

i 



FlC. 5. Double-drug immunosuppres- 
sion with cyclosporin A and steroids. The 
patient (OT 198) had a hepatoma, a-1- 
antitrypsin deficiency, and chronic ac- 
tive hepatitis. The reduction of the cy- 
closporin A dosage after 4 days was be- 
cause of the increasing azotemia. The 
boluses of hydrocortisone were given be- 
cause of a possibly unwarranted suspi- 
cion of early rejection. 



TIME IN DAYS 



85 



Vol. 2, No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



623 



Fie. 6. Immunosuppression with cy- 
closporin A and steroids (plus temporary 
azathioprine) in a 10-year-old girl fOT 
193). Note that the 5-day opening burst 
of prednisone therapy was scaled down 
because of her small size. The temporary 
discontinuance of cyclosporin A and re- 
placement with azathioprine between 
postoperative Days 10 and 15 was be- 
cause of probable cyclosporin nephrotox- 
icity. The patient who was of B blood 
type was given the liver of an A donor. 



t- 


2 







UJ 

Z 


SO 






<=S 




1- ™ 




* E 








o 






100 


UJ 

Z 


80 




60 



z E 

2~ 40 

IX 

0- 20 



tfao 




OT 193 

10 years old 

26 kg 




DISCHARGE 



•""'■ -""V, 



"//////A W ///,'// /77'7 // }'s 



AZATHIOPRINE 



5 1 ° '5 20 25 30 60 90 120 150 

DAYS 




PRE-OP 
Tx 



Time in Days 

at J™ G H« 7 w De h' ati0n fr ° m f t " dard Ster ° id therapV in a patient (0T 2 19) whose Perioperative condition was frail. The 5-day buret of postoperative 
sterols was begun several days postoperatively but had to be repeated when rejection supervened. Before operation the patient ha heiXrenal 
syndrome and encephalopathy and he had been on a ventilator for more than 1 week. Because of defective clotting, efforts .-place cen.rafvenous 

vesils Z:ZZ6tZZT" T Uit d ed ,h n —° Uedhem0rT hEge W " h '^ ' 0SS ° f 2 ° *" ° f bl00d ™< -bclavfin "nd innomi^n 
«t^S Th M?? ,h / ou 8 h 1 cerv,cal a " d thoracotomy incisions, and the bleeding was mechanically controlled before transplantation was 
Started The blood loss from placement of the vascular lines exceeded that incurred during transplanUtion. The patient sur^ved because ot 
prompt corrects of the coagulation abnormalities. He is at home 5 months after transplantation 



86 



624 



STARZL ET AL. 



Hematology 



which remain normal except for nonspecific changes. 
However, during this period, large pyroninophilic cells 
start proliferating in the paracortical zones of the host 
lymph nodes. About 3 days after transplantation, lym- 
phoid cells begin to leave portal vein tributaries randomly 
throughout the graft. The venous endothelium is sepa- 
rated from the basement membrane, and fibrin collects 
in the subendothelial space. After passing through the 
vessel wall, lymphocytes accumulate in the portal tracts. 
Smaller numbers of lymphoid cells migrate through the 
walls of the central vein and the endothelial lining of 
sinusoids. These cells invade the space of Disse and some 
enter between hepatocytes. Immunoglobulins are rare in 
the cytoplasm of the infiltrating cells at this time. 

Associated with cellular infiltration, the cells of many 
sinusoids disintegrate, blood flow through the liver begins 
to decrease, and some centrilobular cells die. As the 
centrilobular necrosis progresses to midzonal necrosis, 
liver function becomes affected. Inspissated bile appears 
in surviving bile canaliculi and lipid droplets accumulate 
in the hepatocytes around the portal tract. Shortly before 
the death of the untreated recipient, foci of fibrinoid 
necrosis sometimes occur in the walls of small branches 
of the hepatic artery associated with deposition of im- 
munoglobulin and complement in the intima and media. 

When rejection is mild, as in pigs (115), or is modified 
by immunosuppressive agents, as in dogs and humans 
(110, 112-114, 116), destruction of hepatocytes ceases, 
cellular infiltration diminishes and may disappear, but 
the central part of the lobular reticulin framework often 
collapses. Accumulation of bile in surviving centrilobular 
hepatocytes and in bile canaliculi occurs; the cause of 
this severe cholestasis is not known and may be second- 
ary to widespread loss or distortion of canalicular micro- 
villi. An alternative possibility has been put forward by 
My burgh et al. (Ill) who drew attention to the progres- 
sive hypertrophy and dilatation of smooth endoplasmic 
reticulum in the centrilobular hepatocytes and suggested 
that these intracellular changes might be caused by hu- 
moral antibody and result in disrupted cholesterol and 
bile salt metabolism with production of excess lithocho- 
late. In some patients, the larger interlobular bile ducts 
disappear as modified rejection continues. This phenom- 
enon is characterized by rapid and relentless rise in serum 
bilirubin (49-51, 116). 

As rejection progresses, connecting bands of reticulin 
are often laid down between the central areas, subdivid- 
ing the lobules. What triggers progression to hepatic 
fibrosis in some grafts is unknown; excess lithocholate 
has been implicated (111). In some patients, cirrhosis is 
produced. Another characteristic feature of chronic re- 
jection is progressive thickening of the intima of the 
branches of the hepatic artery in the homograft. The 
intima contains fat-laden smooth muscle cells and mac- 
rophages, and the lumen is narrowed or occluded. These 
arterial changes occur in many long-surviving liver hom- 
ografts. The accumulation of immunoglobulins and com- 
plement in the altered vessel wall has raised the possi- 
bility that this damage is a late manifestation of rejection 
brought about by circulating antibody. Deposition of 
immunoglobulins is less striking in hepatic grafts than in 
transplant kidneys (117), prompting speculation that he- 
patic rejection was more a phenomenon of cell-mediated 



immunity (as opposed to damage by circulating anti- 
bodies) than has been thought to be the case with reject- 
ing kidney grafts. 

Some histopathologic changes in liver homografts may 
be caused by hepatotoxic drugs, viral hepatitis, or other 
factors. However, a comparison of changes in human 
specimens with those in animal homografts emphasizes 
that the major alterations are immunologic in etiology. 

The Clinical Manifestations of Acute 

Rejection 

Rejection as defined by us (32) and Williams and Calne 
(7) in patients treated with conventional immuno- 
suppression also occurs during treatment with cyclos- 
porin A and steroids. Many patients lose their appetites 
and become depressed. Fever, vague upper abdominal 
pain, and ascites are variable. By palpation, grafts are 
frequently swollen, hard, and mildly tender. Radioiso- 
topes used for liver scanning are poorly concentrated, 
whether these depend upon parenchymal or reticuloen- 
dothelial function. Elevations may occur in serum bili- 
rubin, alkaline phosphatase, and transaminases. Failure 
of synthetic function is most readily detected by meas- 
urements of prothrombin time. 

The various manifestations of rejection occur in differ- 
ent combinations, to variable degrees, and at unpredict- 
able times. The resulting patterns have been categorized 
as "anicteric," "indolent," and "crisis" (32). With a rejec- 
tion crisis, jaundice can develop with astonishing rapid- 
ity, usually just after or accompanied by major rises in 
transaminases. The insidious indolent rejections have 
been the most difficult to reverse. 

All patterns of graft deterioration are nonspecific. 
Proven alternative etiologies include ischemic injury, 
biliary obstruction, cholangitis, hepatitis (B virus, cyto- 
megalovirus, adenovirus, herpes), and drug toxicity. Con- 
sequently, diagnostic procedures, often including chol- 
angiography and needle biopsy, must be considered if the 
postoperative evolution is not satisfactory. In the interim, 
steroid dosage is temporarily increased and returned to 
baseline if a diagnosis other than rejection is established. 
Clinical management is particularly difficult and fraught 
with error if good initial graft function was not achieved. 

A devastating complication of rejection, termed "septic 
hepatic gangrene," occurred in patients who were treated 
with azathioprine, ALG, and relatively low doses of pred- 
nisone. After days or weeks of slightly abnormal hepatic 
function, these patients developed massive hepatic ne- 
crosis with extremely elevated serum transaminase activ- 
ities and deterioration of other measures of hepatic func- 
tion. Raging fevers, bacteremia, and disappearance on 
liver scans of large portions of hepatic parenchyma sig- 
naled regional infarctions within the transplants. Kinking 
of lobar or segmental hepatic arteries was originally 
postulated to be responsible for this complication (5), but 
the most important factor is poorly controlled rejection 
(32). With diminution in total hepatic blood flow, as was 
documented in canine experiments by Groth et al. (31), 
invasion of the ischemic homograft by microorganisms 
from the adjacent intestinal tract is not surprising. 

Study of patients with septic hepatic gangrene and 
confirmatory observations by Brettschneider et al. (118) 
after canine and porcine liver transplantations clarified 



87 



Vol. 2, No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



625 



the interaction between rejection and homograft bacte- 
rial colonization. In animal studies, the normally low 
incidence of positive cultures from liver tissue of dogs 
and pigs increased after sham operations. When an he- 
patic ischemic injury was added by performance of sim- 
ulated autotransplantation, all livers became contami- 
nated, primarily with the same organisms concomitantly 
present in the upper intestine. Bacteria] counts were 
somewhat lower if the common bile duct was left intact 
than when the duct was ligated and bile drainage restored 
by cholecystoenterostomy. The bacterial changes were 
more pronounced in liver homografts transplanted to 
unmodified or immunosuppressed animal recipients. 

Presumably, any ischemic or necrotic area can become 
a septic focus, particularly if the host is given immuno- 
suppressive therapy and cannot respond normally to 
invading microorganisms. The spectrum of resulting in- 
fections under conventional immunosuppression has 
been well studied (32, 119-121). Paradoxically, one of the 
most important ways to prevent nontreatable liver infec- 
tion is to protect the graft with potent immunosuppres- 
sion, especially during the early postoperative period. 
The second obvious step is to provide systematically 
designed antibiotic therapy intraoperatively and for sev- 
eral days thereafter. 

Acute cellular rejection in grafts sampled by biopsy or 
at autopsy has been encountered many months or years 
after transplantation. Some patients were known to have 
discontinued their medications but others had been given 
unwise advice about lowering maintenance medications. 
Increased steroid therapy was given under such circum- 
stances. 

Chronic Rejection 

The diagnosis of chronic rejection was restricted to 
patients whose grafts had arterial intimal thickening, 
hepatic fibrosis, and other findings described previously. 
These findings are not necessarily time-related since they 
often develop within the first few months. Clinical man- 
ifestations of chronic rejection were not much different 
from those of chronic liver failure from endstage disease 
of differing etiologies. Treatment with increased immu- 
nosuppression was ineffective. 

SURVIVAL AFTER TRANSPLANTATION 
The introduction of cyclosporin A and steroids has had 
such a major influence upon results that patients have 
been divided into those treated before and after this 
event. By so doing, it is possible to reexamine several 
factors whose significance was previously unclear. 

Precyclosporin Era (1963 to 1979) 

Between 1963 and the end of 1979, 170 patients had 
liver replacement. In previous publications, the identifi- 



cation of individual recipients by orthotopic transplan- 
tation (OT) numbers made it possible for the interested 
reader to follow their progress from report to report. The 
same code numbers will be used throughout this review. 

In past reports (45, 80, 107), the first 170 recipients 
were divided into the three successive series summarized 
in Table 6 and Figure 8. In the first, second, and third of 
these consecutive groups, 1-year survival was 28.8, 50 
and 34.5%. 

Of the 56 recipients who survived the first postopera- 
tive year, 23 died at the times shown in Table 6. Although 
13 of 23 late deaths were in the second postoperative 
year, deaths occurred as late as 6 years. Of the original 
170 patients, 33 (19.4%) are alive after follow-ups of 2V6 
to 12'/2 years. Twenty have survived for more than 5 
years and four are into the second postoperative decade. 

There was an almost equal division in the total period 
of 1963 to 1979 between adult (>19 years) and pediatric 
(<18 years) recipients. From the sixth month onward, 
the younger patients had about a 10% survival advantage 
(Figure 9). 



N - 111 [1963-1976) 
N = 30 (1976-1978) 
N = 29 (1978-1979) 




18 24 36 48 60 

MONTHS 
Fig. 8. Survival of three consecutive series of patients treated with 
orthotopic Itver transplantation under conventional immunosuppres- 
sion. The dashed lines in Series 2 and 3 are actuarial projections. 




48 



60 



24 36 

MONTHS 
Fie. 9. The life survival of adults vs. children in patients treated with 
conventional immunosuppression. 



Table 6. Late Deaths in 170 Patients During Precyclosporin A Era (1963-1979) 





No 


Alive after 
1 year 


Died after 
1 year 


Time of late death to 
nearest postop month 


Alive 
now 


Years follow-up 
of survivors 


Series 1 

Series 2 
Series 3 


111 

30 
29 


31 (28.8%) 

15 (50%) 
10 (34.5%) 


18 

4 

1 


12, 13, 13, 13, 14, 16, 17, 20, 20, 21 

25, 26, 28, 30. 36, 41, 54, 72 
17, 23, 49. 56 
13 


13 

11 
9 


614-1254 

4H-5'A 
2V4-4W 



88 



626 



STARZL ET AL. 



Hepatology 



Table 7 summarizes the results in the Cambridge- 
King's College trials from 1968 through early 1980 (53, 
122). In this series, 22 (23.7%) of the first 93 recipients 
lived for at least 1 year, with 11 subsequent deaths during 
the second to sixth years; the 11 survivors had been 
followed for 1 to 6 years. The better 1-year survival in 
the American compared to the English trial (33 vs. 24%) 
was partly illusory since Calne and Williams accepted for 
surgery few pediatric patients with whom (Figure 9) our 
best results were obtained in those years. 

Our results in the pediatric age group after transplan- 
tation for different indications are given in Table 8. 
Similar information for adult recipients is provided in 
Table 9. 

Cyclosporin Era (1980 to 1982) 

The longest follow-ups for our patients treated with 
cyclosporin A and steroids are only 2'/fi years. During the 



Table 7. Actual 1-Year Survival" in Cambridge/King's 
College Series of 93 Cases (1968 to February, 1980) 



93 



77 (82.8%) 



31 (33.3%) 



22 (23.7%) 



" Information from (122). Of the 22 one-year survivors. 11 had subsequently 
died from 1 to more than 5 years postoperatively The other 11 were living in 
their second to sixth postoperative year An actuarial projection of this data 
beyond 1 year is depicted in Figure 10. 



Table 8. Indications for Transplantation and Survival in 

Pediatric Patients (S18 Years) from 1963 Through 1979 

(Precyclosporin A) 









Survival (months) 
























>1 


>2 


>6 


>12 


Now" 


Biliarv atresia 


51 


37 


27 


16 


14 


7 






(73%) 


(53%) 


(31%) 


(27%) 


(14%) 


Inborn meta- 


13 s 


12 


11 


8 


8 


6 


bolic errors 




(92%) 


(85%) 


(62%) 


(62%) 


(46%) 


Chronic aggres- 


13 


11 


10 


7 


5 


3 


sive hepatitis 




(85%) 


(77%) 


(54%) 


(38%) 


(23%) 


Hepatoma 


3' 


3 


3 


2 


2 





Neonatal hepa- 


2 


1 


1 


1 


1 





titis 














Congenital he- 


2 


1 


1 


1 


1 


1 


patic fibrosis 














Secondary bili- 


•yi 


2 


2 


2 


2 


1 


ary cirrhosis 
















86 


67 


55 


37 


33 


18 






(78%) 


(64%) 


(43%) 


(38%) 


(21%) 



1 Follow-ups for living patients are 2W to 12'/i years. 
b Inborn errors 

a-1-antitrypsin deficiency 

Wilson's disease 

Tyrosinemia 

Type IV glycogen storage disease 



9 
2 
1 
1 

13 



' Five other patients had incidental malignancies (4 hepatomas and 
1 hepatoblastoma) in their excised livers. The principal diagnoses in 
these five cases were biliary atresia (3 examples), a-1-antitrypsin defi- 
ciency (1 example), and congenital tyrosinemia (1 example). The diag- 
nosis of the neoplastic change was known in advance only in 2 of the 5 
cases. 

d Secondary to trauma or choledochal cyst (one each). 



Table 9. Indications for Transplantation and Survival in 

Adult Patients (>19 Years) from 1963 Through 1979 

(Precyclosporin A) 

Survival (months) 







>1 


>2 


>6 


>12 


Now" 


Chronic aggres- 


33 


21 


17 


14 


11 


7 


sive hepatitis 




(64%) 


(52%) 


(42%) 


(33%) 


(21%) 


Alcoholic cir- 


15 


8 


5 


4 


4 


3 


rhosis 




(53%) 


(33%) 


(27%) 


(27%) 


120%) 


Primary malig- 


15' 


9 


7 


4 


3 


1 


nancy 




(60%) 


(47%) 


(27%-) 


(20%) 


(7%) 


Sclerosing cho- 


7 


7 


4 


2 


2 





langitis 














Primary biliary 


6 


3 


3 


2 


1 


1 


cirrhosis 














a- 1 -antitrypsin 


2 


1 


1 











deficiency 














Secondary bili- 


2' 


1 


1 


1 


1 


1 


ary cirrhosis 














Hemochromato- 


1 


1 














sis 














Protoporphyria 


1 

















Budd-Chtan 


1 


1 


1 


1 


1 


1 


syndrome 














Acute hepatitis 


1 


1 


1 











B 
















84 


53 


40 


28 


23 


14 






(63%) 


(48%) 


(33%) 


(27%) 


(17%) 



" Follow-ups for living patients are 7}A to 8 ] /i years. 

b Seven hepatomas, 5 duct cell carcinomas (Klatskin), 1 cholangio- 
carcinoma, 1 hemangioendothelialsarcoma, and 1 unclassified sarcoma. 

' One example each of possible duct hypoplasia and choledochal 
cyst; both patients had had multiple operations. 



first 9 months of 1980, 14 patients entered into this trial 
at the University of Colorado (108); 2 died during the 
operation, and 1 died after 19 days. The other 11 patients 
survived for more than 1 year. Eight are alive after 21 to 
28 months. The 1-year survival of 78.6% could have 
represented a sampling accident. However, at the Uni- 
versity Health Center of Pittsburgh, 26 patients were 
treated in 1981. Five died in the first postoperative 
month, and additional deaths occurred in the second, 
third, and fourth months. With follow-ups of 6 months to 
more than 1 year, the remaining 18 (69.2%) recipients are 
alive and at home; none has poor hepatic function. 

The pattern of predominantly early mortality seen in 
1980 and 1981 has continued into 1982. Of the first 27 
recipients treated in 1982, 8 died. Six, one, and one of 
these deaths were in the first, second, and third postop- 
erative months, respectively. 

It is too early to assess the rate at which late deaths 
will occur, since only 18 patients treated with cyclosporin 
A have reached or passed the 1-year mark. Of these, 
three died in their thirteenth, sixteenth, and twentieth 
postoperative months for reasons that will be considered 
in the next section. 

The actuarial survival calculated from the cases in the 
cyclosporin era studied to date is shown in Figure 10. In 
comparison to our previous experience in the precyclo- 
sporin era and in comparison to the Cambridge-King's 
College compilation, survival has more than doubled. 



89 



Vol. 2, No. 5. 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



627 



80- 


|l Cyclosporin A « x N = 67 (1980-1982) 

\ Azathioprine • • N = 170 11963-1979} 

^ Cambridge o o N = 93 11968-1980 Feb ) 






50 


\v "\^ 


40- 




20- 

n- 


~~ — -o 



6 12 16 24 30 

MONTHS 

Flo. 10. The actuarial survival of patients treated with cyclosporin 
A and low-dose steroids compared to the actual 1-year survival obtained 
under conventional immunosuppression by us (azathioprine) and the 
workers at Cambridge The data for the Cambridge curve were obtained 
from published reports (53, 122). 

The results calculated for the first 12 postoperative 
months have not been different in adults and children 
(Figure 11). A breakdown of results according to original 
disease in the pediatric and adult cases is provided in 
Tables 10 and 11. 

The influence of cyclosporin A upon survival in the 
Cambridge-King's College trials has not been clearly 
defined, because the drug has not been regularly used 
and because it was started late in most cases after an 
initial course of azathioprine and steroids. Nevertheless, 
improved results have been attributed by Calne et al. 
(53) to better immunosuppression. 

CAUSES OF MORTALITY 
Precyclosporin Era 

Early Death. The appalling early mortality after liver 
transplantation has prompted exhaustive clinical-patho- 
logic analyses of our failed cases. Using the OT code 
numbers of the patients, the results have been reported 
in such a way that individual assessment of almost every 
early death in the first 170 cases can be made by the 
interested reader (43, 45, 80). Mortality figures included 
the use of grafts damaged by ischemia, massive operative 
hemorrhage, thrombosis of the reconstituted homograft 
blood supply, intraoperative cerebral air embolism (44), 
unsuspected recipient abnormalities (such as prior 
thrombosis of the portal vein), hopeless anatomical sit- 
uations created by multiple previous operations, irre- 
versible preexisting debilitation, and (above all) defective 
biliary tract reconstruction. 

With or without such factors, overwhelming infection 
was frequently a terminal event. At autopsy, histopath- 
ologic findings of acute rejection were found in 10 to 15% 
of cases, prompting speculation that over immuno- 
suppression, especially with prednisone, may have been 
responsible for unnecessary deaths (43). 

When serial biopsies were obtained in later cases (45, 
80), this simplistic view had to be revised. Many biopsies 
contained unmistakable findings of rejection for which 
the appropriate response had been more steroids. After 
death caused by infection, the findings of rejection were 
absent. The conclusion was reached that even after a 
perfect operation, the unacceptable acute mortality 
would remain until improved immunosuppression be- 



80 



5 60 
c/i 

O 
(X 




20 



Cyclosporin A 
Children » — ~« N = 26 
Adulls O— — o N = 41 



3 6 9 12 

MONTHS 
Fig. 1 1 . The 1 -year actuarial survival of adults vs. children after liver 
transplantation under immunosuppression with cyclosporin A and ste- 
roids. 



Table 10. Indications for Transplantation in Pediatric 

Patients (<18 Years) from Mid- 1980 to May, 1982 

(Cyclosporin Era). Follow-Ups for Survivors Are 1-21 

Months 





No. 


Living 


Biliary atresia" 


11 


8 


Q-1-antitrypsin deficiency'' 


4 


2 


Chronic aggressive hepatitis 


2 


2 


Bvler's disease' 


2 


1 


St idarv biliarv cirrhosis 1 * 


1 





Budd-Chiari svndrome 


1 





Neonatal hepatitis 


1 


1 


Subacute Wilson's disease* 


1 


1 


Tyrosinemia'' 


1 


1 


Type I glycogen storage disease'' 


1 


1 


Sea-blue histiocyte syndrome'' 


1 


1 




26 


18 

am i 



' Two had Alagille's syndrome. 

h Inborn errors of metabolism. The children with tyrosinemia and 
sea-blue histiocyte syndrome had incidental hepatomas in their cir- 
rhotic livers. 

Diagnosis equivocal in one case. 

'' Choledochal cyst with multiple operations. 

Table 11. Indications for Transplantation in Adult Patients 

(>19 Years) from March 1. 1980 to May I. 1982 (Cyclosporin 

Era). Follow-Up for Survivors Was 1-27 Months 



No. 



Living 



Chronic aggressive hepatitis 

Malignancy" 

Primary biliary cirrhosis 

Secondary biliary cirrhosis 

2 trauma 

1 Caroli 

1 choledochal cyst 
Sclerosing cholangitis 
a-1-antitrypsin deficiency 
Budd Chiari syndrome 
Adenomatosis" 



3 


2 


2 


1 


2 


1 


1 


1 


1 


28 




(68%) 



"One patient in each group had previous (1 and A\'i years earlier) 
right hepatic trisegmentectomy. At transplantation, the regenerated 
left-lateral segment was replaced with a whole liver. 



90 



628 



STARZL ET AL. 



Hepatology 



came available. Both nonimmunologic and immunologic 
complications have continued to cause early deaths in 
the cyclosporin era albeit at a reduced rate. 

Deaths After 1 Year. Assessment of the reasons for 
late death in older cases may help to predict the spectrum 
of problems which can be expected in future patients. 
The causes of mortality after 1 year in patients treated 
with conventional immunosuppression are listed in Table 
12. Recurrent liver failure was responsible for death in % 
of 23 patients, if the four who died after attempted 
retransplantation are included. In three patients, the 
main mortality factor was recurrence of malignancy. One 
of the late deaths was caused by chicken pox hepatitis 
during an epidemic on the transplantation ward. The 
patient (OT 112) whose death was classified under self- 
abuse was an alcoholic, drug abuser, and derelict who 
resumed the same life style after transplantation. Fifty- 
six months after transplantation, he was found uncon- 
scious in a ditch in Florida and died of pneumonitis. 

The dominant pathologic diagnoses of the 24 first or 
second grafts which functioned chronically in these 23 
patients are listed in Table 13. Chronic rejection was the 

Table 12. Causes of 23 Deaths" After 1 Year of Patients 

Treated with Azathioprine (or Cyclophosphamide), 

Prednisone, and ALG 



Cause of Heath 



No. 



Predominant liver failure 
Liver failure plus sepsis 
Early after retransplantation 
Recurrent cancer 
Predominant sepsis 
Self-abuse 

Total 



8 
5 
4* 
3 
2 
1 

23 



" Deaths were usually caused by multiple problems, but only the 
single most important factors are listed. 

h Infection invariably contributed to death after retransplantation. 
In addition, two patients had lethal technical complications and two 
more had rejection. 

Table 13. Principal Pathologic Changes in 24 Liver Grafts 

that Had Functioned Under Conventional 

Immunosuppression for 339 to 2,190 Days Before the Death 

of the Patient." In 5 of the 24 Grafts, Two Diagnoses Were 

Given 



Pathologic changes 



No. 



Chronic rejection 

Biliary obstruction 

Recurrent cancer 

Chronic hepatitis 

Portal vein thrombosis 

Chronic cholangitis 

Chicken pox, hepatitis with necrosis 

Early alcoholic hepatitis 

Diffuse fatty changes with centrilobular necrosis 

Total 



11 
6 
4 
2 
2 
1 
1 
1 
1 

29 



" These 24 grafts were from the 23 patients who died after 1 year 
(Table 12). Seven of the 23 patients were given two livers, but chronic 
function (682 plus 403 days) was obtained from both organs in only one 
case (OT 103); in the other six, the pathologic changes are tabulated 
only for the long-surviving grafts. Most of the specimens were obtained 
at autopsy, but a few were from surgical or closed biopsies. 



most common final diagnosis, followed by biliary obstruc- 
tion and recurrent cancer. There were two examples each 
of chronic hepatitis and portal vein thrombosis. 

These findings differ from those reported by Calne et 
al. (53) in 11 patients who died after 1 year; recurrent 
carcinoma was the main homograft abnormality in five 
patients. In the other six grafts, there was biliary sludge 
and cholangitis. Chronic rejection was not mentioned. 
Our findings suggest that ongoing problems with immu- 
nologic control will continue to take a gradual toll long 
after successful transplantation, whereas interpretation 
of the pathologic findings in the English recipients is 
different. Clarification of this divergence of observations 
will be important. 

Cyclosporin Era 

Twenty-two of the 67 patients treated in 1980 to 1982 
died. Three deaths were after 1 year, and the other 19 
were early. 

Early Death. Fourteen of 19 early deaths, including 
two on the operating table, occurred in the first postop- 
erative month. In the second, third, and fourth postop- 
erative months, there were 1, 1, and 2 more death(s), 
respectively (Table 14). 

Eight deaths were directly attributable to preexisting 
anatomic conditions including multiple previous opera- 
tions (OT 178), earlier portacaval shunt (OT 180), and 
right-to-left pulmonary shunts secondary to the liver 
disease (systemic arterial pO_. was 30 mm Hg) which did 
not subsequently close (OT 203). However, the most 
important abnormalities were in liver blood supply or the 
vena cava (OT 217, 220, 228, 232, 233) which had not 
been diagnosed preoperatively. At operation, it was not 
possible to vascularize adequately homografts in 4 of 
these latter 5 recipients. In the fourth (OT 233), the 
superior vena cava was discovered at autopsy to have 
been replaced by two innominate veins which descended 
into the abdomen and emptied into the inferior vena 
cava below the renal veins. During the vena caval cross- 
clamping of the anhepatic phase of transplantation, the 
child developed an acute superior vena caval syndrome 
with irreversible brain injury. 

Eight early deaths were technical and thus avoidable, 
including the use of inadequately preserved grafts (OT 
185 to 188), hepatic artery thrombosis (OT 183, 225), and 
complications of biliary tract reconstruction (OT 201, 
208). Problems in preservation were encountered in the 
first four cases at a new institution. 

Deaths After 1 Year. Patients died late (Table 14) of 
recurrent Budd-Chiari syndrome (OT 174), recurrent 
duct cell carcinoma (OT 176), and after retransplantation 
after a primary graft was chronically rejected (OT 181). 

THE POSSIBILITY OF RETRANSPLANTATION 
In assessing ways of reducing patient mortality, it was 
obvious almost from the beginning that aggressive at- 
tempts at retransplantation offered the only chance of 
survival for many patients whose first grafts failed either 
early or late. Such efforts, which have been made in 27 
patients (2 of the 27 also were given third grafts) since 
1968 (Figure 1), usually have born bitter fruit. The few 
successes that have been achieved have served as an 
important stimulus for further trials. 



91 



Vol. 2, No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



629 



Table 14. Major Causes of 22 Deaths in Cyclosporin Era 



Age 



Pathology before transplant 



Major causes of death 



Postoperative 

month of 

death 



176 


33 


F 


178 


37 


M 


180 


40 


M 


181 


16 


F 


183 


8 


F 


185 


56 


M 


186 


17 


F 


187 


37 


F 


188 


46 


M 


196 


36 


F 


201 


4 


M 



208 42 



216 


2 


F 


217 


44 


M 


220 


8 


F 


225 


44 


M 



228 



Budd-Chiari syndrome, portacaval shunt 

Sclerosing cholangitis, duct cell carcmoma 
Secondary biliary cirrhosis, gunshot wound 

to liver 
Sclerosing cholangitis, portacaval shunt 
Budd-Chiari syndrome 



Byler's disease 

Klatskin's tumor 

Secondary biliary cirrhosis, Caroli's disease 

Chronic aggressive hepatitis, portacaval 

shunt 
Chronic aggressive hepatitis 
Chronic aggressive hepatitis 
a- 1 -antitrypsin deficiency disease 

a-1-antitrypsin deficiency disease, exten- 
sive pulmonary A-V shunt 



Chronic aggressive hepatitis, o-l -antitryp- 
sin deficiency disease, primary biliary 
cirrhosis 

Primary biliary cirrhosis 



Biliary atresia, Kasai operation 

Chronic aggressive hepatitis, splenectomy. 

portal vein hypoplasia" 
Secondary biliary cirrhosis, choledochal 

cyst, portal vein thrombosis" 
Q-1-antitrypsin deficiency disease 



Alagille's syndrome, absent hepatic ar- 
tery", hypoplastic portal vein" 

Biliary atresia, Kasai operation, absent in- 
ferior vena cava", malrotation" 

Biliary atresia, Kasai operation, absent su- 
perior vena cava with innominate drain- 
age into inferior vena cava" 



Recurrent Budd-Chian syndrome, liver 

failure, sepsis 
Recurrent duct cell cancer 
Operative 

Operative 

1st graft: chronic rejection 

2nd graft: acute rejection 

3rd graft: liver failure, renal failure 

Hepatic artery thrombosis 

Graft necrosis, sepsis 

Graft necrosis, sepsis, bile leakage 

Graft necrosis 

Graft necrosis, sepsis 

Systemic aspergillosis 

Hemorrhage during exploration of intra- 
hepatic abscess and mycotic aneurysm 

1st graft graft hypoxia due to pulmonary 
A-V shunt 

2nd graft: graft hypoxia; rejection 

3rd graft graft hypoxia; cerebral hemor- 
rhage 

Hemorrhage from hepatic artery, bile duct 
fistula 

Rejection; sepsis due to duodenal stump 
leakage after total gastrectomy for stress 
ulcer hemorrhage 

Chronic rejection, liver failure, sepsis 

Operative 

1st graft graft necrosis 
2nd graft: cerebral hemorrhage 
1st graft: rejection, hepatic artery throm- 
bosis 
2nd graft: rejection, sepsis 
G.aft necrosis 

Diffuse clotting in graft 

Perioperative brain death 



13 

1 



1 
20 



" Anomalies or abnormalities not known before operation. 



The attempts at retransplantation in 27 patients are 
summarized in Table 15. Eighteen of 27 second trans- 
plantations were within the first 3 months, 3 were be- 
tween 3 and 12 months, and 6 were after 12'/2 to 29 
months. 

Extended subsequent survival occasionally was 
achieved with early and later retransplantation. The fate 
of six patients whose lives were significantly prolonged is 
summarized in Table 16. Much of life for the first four 
recipients was a nightmare of morbidity because of the 
combination of high steroid needs and slowly failing graft 
function. However, the two patients who had successful 
retransplantation in the cyclosporin A era, 1 and 3 weeks 
after primary grafting, have had perfect results and are 
at home 6 and 12 months later on daily prednisone doses 
of 5 and 15 mg per day, respectively. In the first patient, 



the primary graft had developed a huge fungus abscess; 
in the second patient, the first graft had been rejected. 

The performance of retransplantation has sometimes 
been surprisingly easy. The procedure has been greatly 
simplified by retaining cuffs from the suprahepatic and 
intrahepatic vena cava and from the portal vein of the 
first graft. Usually, it has been necessary to perform the 
arterial anastomosis proximal to the previous site. 

THE INFLUENCE OF ORIGINAL DISEASE UPON 
RESULTS 

Evaluation of the influence on survival of preexisting 
hepatic disease is complicated by the fact that many 
patients have more than one diagnosis (Table 17). Ten 
(14.9%) of our last 67 patients had two coexisting hepatic 



92 



630 



STARZL ET AL. 



Hepatology 



Table 15. Attempt at Retransplantation in 27 Patients" ' 



Months between first 
and second transplanta- 
tion 



Months survival after sec* 
ond transplantation 



Conventional 21 <1 x 9 patients, <1 x 11 patients, 1, 1, 

immuno- VA, 2, 2\ 3, 3'A, 5'/4, lfc, l 1 *, V/*, 2, 6, 12, 

suppression 6, 12':, 16'?, 22'/2, 27, 13, 16 

29 

Cyclosporin— 6 <1 X 5 patients, 19 <1 x 3 patients, 3&, 

Steroids 6 r , 12' 

" Two of the 27 had third transplantations, 1 and 7V4 weeks after 
second transplantation had failed. 

h One patient had a chimpanzee heterograft on the second occasion. 
1 Alive. 

Table 16. Time of Retransplantation in Six Patients Who 
Subsequently Lived for >6 Months 



Duration of first graft 



Survival in months after second 
graft 



16 


2 months 


11 


98 


5W weeks 


16 


103 


22V2 months 


13 


156 


2 weeks 


6 


191 


3 weeks 


12' 


209 


1 week 


6' 



" In cyclosporin series, both alive. 

Table 17. Patients in Cyclosporin A Series (67 Cases) with 
Multiple Diagnoses 



OTNo 


Main diagnosis 


Other diagnosis 


176 


Cholangiocarcinoma 


Sclerosing cholangitis 


188 


Chronic aggressive hepa- 


Heterozygous o-l-anti- 




titis 


trypsin disease 


198 


Hepatoma 


a-1-antitrypsin disease, 
chronic aggressive 
hepatitis 


206 


Tyrosinemia 


Hepatoma, diagnosed at 
previous operation 


208 


Chronic aggressive hepa- 
titis 


a- 1 -antitrypsin disease 


218 


Type I glycogen storage 


Multiple hepatic adeno- 




disease 


mas 


222 


Sea-blue histiocyte syn- 


Hepatoma, diagnosed at 




drome 


previous operation 


225 


a- 1 -antitrypsin disease 
(Pi ZZ) 


Hemachromatosis 


227 


Hepatoma 


Chronic aggressive hepa- 
titis 


234 


Hepatoma 


Chronic aggressive hepa- 
titis 



diseases; however, in most of our analyses (Table 8 to 
11), only the most important diagnosis was tabulated. 

No disease for which transplantation has been used 
can be categorically excluded for further trials. This can 
be appreciated by examination of results with different 
kinds of disease in pediatric and adult patients before 
and after the introduction of cyclosporin A (Tables 8 to 
11). 

Nevertheless, special problems can be expected in 
treating some hepatic diseases. In the past, some patients 
with biliary atresia died because of unexpected anomalies 
which jeopardized performance of a technically satisfac- 
tory transplantation (32); specific examples are listed in 
Table 14. 



Noncompliance may be a problem in patients treated 
for Laennec's cirrhosis. Of our first nine patients with 
alcoholic cirrhosis, eight died too soon to evaluate this 
potential problem (123). There were several subsequent 
successes (Table 9); only one recipient returned to toxic 
drinking. 

The Special Problem of Hepatic Malignancy 

The possibility that immunosuppression may acceler- 
ate metastatic tumor growth has been recognized (32). 
Evaluations of transplantation in treating hepatic malig- 
nancies were made in 1981 by Iwatsuki et al. (124) and 
by Calne (122). Although recurrent disease exceeded 50% 
in both series, the results did not allow definitive rec- 
ommendations about continuation of these efforts. 

Our case material has been divided into three groups. 
In the first category were three children whose livers 
contained malignant tumors (2 hepatocellular cancers, 1 
hepatoblastoma) that had not been suspected preopera- 
tively (Table 18). The two recipients who survived op- 
eration have no evidence of recurrence after 4Vt to 12'/2 
years. These observations suggest that malignancies can 
be cured by liver replacement. 

In the second category were eight patients, all treated 
early in our experience, who died less than 1 month after 
liver replacement for hepatic or duct cell cancer (Table 
19). From this case collection, it was possible to deter- 
mine by autopsy studies the frequency with which extra- 
hepatic tumor spread had been missed in preoperative 
evaluation. Only 1 of the 8 recipients had metastases. 

Twenty-two additional patients, including one (OT 
176) whose neoplastic lesion was missed at the initial 
pathologic examination, lived long enough to evaluate 
the influence of transplantation upon the malignancy 
(Table 20). The first 12 were treated in the precyclosporin 
era; nine recipients developed metastases. A tenth pa- 
tient with an unclassified sarcoma had extrahepatic me- 
tastases at transplantation, and she is well 5V> years later 
with no clinical evidence of advancing disease. Five pa- 
tients survived for longer than 1 year; even for those who 
eventually died of metastases, the extension of useful life 
seemed to be worthwhile. 

Ten more patients have been treated in the cyclosporin 
era (Table 20). Three had duct cell carcinomas (one with 
sclerosing cholangitis); one of whom (OT 185) died early 
without evidence of residual cancer. The second patient 
(OT 176) died of metastatic cholangiocarcinoma after 1 
year. The third (OT 200)' is alive in the ninth postopera- 
tive month and has metastases. All patients with hepa- 
tocellular carcinoma are alive. The tumors were enor- 
mous in three cases. In the other four, the lesions were 
smaller but could not be resected with conventional 
techniques because of coexisting cirrhosis. It seems likely 
that selected patients with hepatic or possibly biliary 
duct malignancies can be effectively treated with trans- 
plantation; however, no patient with duct cell carcinoma 
has ever been cured (53, 122, 124). The prospects may be 
more favorable for young patients whose hepatocellular 
cancers could be treated with conventional partial hep- 
atectomy were it not for coexisting cirrhosis. 

Heroic efforts may be justifiable for patients with the 
recently described "fibrolamellar hepatoma" which is 



93 



Vol. 2, No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



631 



Table 18. Patients Treated for Endstage Benign Liver Disease Whose Removed Livers Contained an Unsuspected Primary 
Liver Malignancy as Well. All Were Treated with Azathioprine, Prednisone, and ALG 



Patient 



Age 

<yr) 



Primary indication for transplant 



Incidentally found liver ma- 
lignancy 



Survival 



Tumor recur- 
rence 



OT 33 3 F Biliary atresia Hepatoma Alive 12% years 

OT 80 7 F Biliary atresia Hepatoma Operative death 

OT 142 5 F a- 1 -antitrypsin deficiency Hepatoblastoma Alive at 4V4 years 



No 
No 



Table 19. Patients with Known Primary Liver Malignancy Whose Early Death After Transplantation Precluded 
Observations of the Course of the Malignancy. All Were Treated with Conventional Immunosuppression Before 1975 



Age 
(yr) 



Diagnosis 



Survival (days) 



Metastases at autopsy and lo- 
cations 



Main cause of death 



OT2 


48 


M 


Hepatoma, cirrhosis 


21 


No 




Pulmonary emboli, sepsis 


OT3 


68 


M 


Bile duct carcinoma 


8 


No 




Sepsis, pulmonary emboli. 








(Klatskin's 


i tumor) 








gastrointestinal bleeding 


OT4 


52 


M 


Cholangiocarcinoma 


5 


Bone, 


lung, kidney. 


Pulmonary emboli, hepatic 








cirrhosis 






lymph nodes 


failure, pulmonary edema 


OT5 


29 


F 


Hepatoma 




24 


No 




Sepsis, bile peritonitis, hepatic 
failure 


OT6 


29 


M 


Hepatoma 




7 


No 




Hepatic failure, sepsis 


OT7 


24 


F 


Hepatoma 




17 


No 




Pneumonitis 


OT25 


45 


M 


Hepatoma 




29 


No 




Bile peritonitis, sepsis, hepatic 
failure 


OT79 


60 


M 


Bile duct carcinoma 


19 


No 




Hepatic failure due to biliary 








(Klatskin's 


tumor) 








obstruction 



characterized by indolent primary growth and late me- 
tastases (125, 126). Three of our last 10 patients with 
hepatic malignancy have had this diagnosis. In all three, 
the tumors were massive. In one patient who was treated 
more than 2 years ago (OT 172), a large tumor thrombus 
originating in a hepatic vein was extracted at operation 
from the vena cava and right atrium. He is tumor-free. A 
second patient, who also is tumor-free after almost 1 year 
(OT 194), had complete obstruction of the portal vein by 
tumor. A third patient treated 2 months ago (OT 231) 
developed recurrence in the residual lateral segment after 
a right trisegmentectomy 4Vi years earlier. The tumor- 
laden residual segment was replaced with a new liver 
with a satisfactory result thus far. 

At the moment, the prospects for cure seem bleak for 
patients with duct cell carcinomas, and scarcely better 
for those with unresectable conventional hepatocellular 
carcinomas. Patients with smaller malignancies in livers 
with other diseases, or those with fibrolamellar hepato- 
mas may be more susceptible to treatment. 

Recurrence of Other Hepatic Diseases 

In pediatric recipients (Tables 8 and 10), recurrence of 
nonneoplastic hepatic disease has not been observed. A 
special feature of transplantation in the younger age 
group has been the metabolic "cure" of at least five and 
possibly six so-called inborn errors (Tables 8 and 10) 
(126-131). With cyclosporin A, the prospects of using 
transplantation to treat children with a variety of dis 
eases has been heightened because chronic high-dose 
steroid therapy can be avoided (132). 

That the original disease can be recapitulated in hom- 
ografts was demonstrated in adult recipients. Two pa- 
tients with Australia antigenemia and chronic aggressive 
hepatitis redeveloped their original disease and died 
(133). Other patients with recurrent or newly developing 



Australian antigenemia have lived for as long as 8 years 
with the carrier state. It has been our policy to treat 
HBsAG positive transplant recipients with hyperimmune 
globulin postoperatively. Antigenemia has returned in 
every case, sometimes after becoming undetectable for 
months. With such treatment, Johnson et al. reported 
permanent antigen clearing in a patient (134). 

Recurrent primary biliary cirrhosis (135) as described 
in the English series was not seen in five grafts studied at 
autopsy after a few days to more than 6 months, and five 
patients still living have had no evidence of recurrence in 
spite of the reappearance of antimiochondrial antibodies 
in the longest survivors (2W and almost 4 years). 

We have treated three patients for the Budd-Chiari 
syndrome. One (OT 174) developed the same disease in 
the graft and died after 15 months. The terminal course 
of this patient was triggered by unwise discontinuance of 
anticoagulant therapy in preparation for a closed liver 
biopsy. Calne et al. (53) reported a similar occurrence. 

The Influence of Previous Operations 

The technical problems engendered by prior surgery 
have been so great that the Cambridge-King's College 
Team consider multiple earlier operations as a relative 
contraindication to transplantation. However, the major- 
ity of candidates evaluated by us and the English workers 
have had previous operations. The influence of this factor 
was evaluated in the first 40 patients treated with cy- 
closporin A and prednisone (Table 21) in whom the 
results were more analyzable than in our earlier cases. 

Fourteen of 40 recipients had major procedures on 
portal triad structures (Table 21) including six portal- 
systemic shunts and five biliary duct reconstructions. 
The risk of death in the first postoperative month was 
double that in patients with lesser or no earlier opera- 
tions. There were two operative deaths (OT 176 and 180) 
(Table 21) including one that occurred while trying to 



94 



632 



STARZL ET AL. 



Hepatolocy 



Table 20. Patients with Primary Hepatic Malignancy. The Diagnosis of Neoplasia Was Known in Advance of 
Transplantation Except in OT 176. Postoperative Survival Was at Least 2 Months for All But One Patient 



Age 



Diagnosis 



Survival 
(months) 



Malignancy 

factor in 

death 



OT8 


[',: 


F 


OT 14 


16 


F 


OT 15 


43 


M 


OT23 


15 


M 


OT26 


11 


F 


OT45 


53 


M 


OT78 


48 


M 


OT90 


41 


M 


OT 102 


51 


F 


OT 111 


9 


F 



OT 114 



OT 121 32 



OT 172 


24 


M 


OT 176 


33 


F 


OT 185 


56 


M 


OT 194 


26 


M 


OT 198 


47 


F 



OT 200 27 M 

OT 206 2 F 

OT 227 53 M 

OT231 23 F 



OT 234 



Hepatocellular cancer 
Hepatocellular cancer 



Precyclosporin Era 
>13 



>14 

Hepatocellular cancer, cirrhosis >11 

Hepatocellular cancer >4 

Biliary atresia, hepatocellular cancer >2 

Hemangioendothelial sarcoma >2 

Bile duct carcinoma (Klatskin's tumor) >24 

Bile duct carcinoma (Klatskin's tumor) >54 

Bile duct carcinoma (Klatskin's tumor) >2 

Tyrosinemia, hepatocellular cancer >3 

Sarcoma (undetermined cell type) of liver >68 (Alive) 
invading diaphragm, metastasis to right 
lung and peritoneum 



Hepatocellular cancer 



>5 

Cyclosporin Era 



Hepatocellular cancer" >27 

Sclerosing cholangitis, duct cell carci- >12 

noma'' 

Duct cell carcinoma (Klatskin's tumor) >V6 

Hepatocellular cancer" >1 1 

Q-1-antitrypsin disease, cirrhosis, hepato- >9 

cellular cancer 

Duct cell carcinoma (Klatskin's tumor) >8 

Tyrosinemia, hepatocellular cancer >7 

Cirrhosis, hepatocellular cancer >3 

Hepatocellular cancer", previous right tri- >2 

segmentectomy 

Hepatocellular cancer, cirrhosis >1 



Brains, lungs, iiv"- i;er abdominal or- 
gans 

Diaphragm, retroperitoneal space, liver, 
pancreas 

Lungs, liver, diaphragm 

Brain, lungs, liver, retroperitoneal space 

Lung 

Brain, lungs, liver, spleen, pericardium, 
peritoneum, stomach, pancreas, kidney 

Liver, bile duct at reoperation. No au- 
topsy 

Bile duct, liver, duodenum at reoperation 
No autopsy 

None 

Microscopic metastasis in the lung and 
paraaortic lymph nodes at autopsy 

Grossly fine intraabdominal and pulmo- 
nary metastases at time of transplan- 
tation which have been quiescent for 
5'/fc years 

None 



None 

Liver, duct, peritoneum 

None 
None 
None 



Liver, operative wound 

None 

None 

None 

None 



Main 

Major 

Main 
Main 
None 
Main 

Main 

Main 

None 
Minor 



None 



Alive 
Main 

None 
Alive 
Alive 

Alive 
Alive 
Alive 
Alive 

Alive 



' Fibrolamellar. 

s Diagnosis of cancer missed in surgical specimen, but diagnosed at surgical margin and within the native liver by reexamination 9 months 



later. 



Table 21. Influence of Previous Major Hepatobiliary 

Surgery" Upon Results in 40 Consecutive Cases 

(Cyclosporin Era) 





No. 


Survival (months) 




>1 


>2 >6 


Previous major operation(s)" 
No major operation'' 


14 
26 


10 
22 


10 10 

21 19 



n Six portal-systemic shunts (5 portacaval, 1 distal splenorenal). 5 
bile duct reconstructions, and 3 portoenterostomies (Kasai). 

* Previous exploration, open liver biopsy, cholecystectomy, T-tube 
insertion, and splenectomy were not counted as major prior procedures 
although the resulting vascular adhesions were usually troublesome. 
Twelve of the 26 patients had one or more of these "minor" previous 
operations including 4 cholecystectomies. 3 T-tube insertions, and 1 
splenectomy. 



take down a portacaval shunt. The portal vein after 
portacaval shunt (especially side to side) may have sub- 
optimal length and can be so sclerotic that suturing is 
difficult or impossible. For patients who survive the first 
postoperative month, the background of previous major 
operations was no longer a factor (Table 21). These 
results suggest that a prudent decision may be against 
transplantation in patients with a complex surgical his- 
tory, but that a "clean abdomen" is not a criterion of 
selection. 

THE OPTION OF AUXILIARY LIVER 
TRANSPLANTATION 

The alternative to orthotopic liver transplantation is 
transplantation of an extra liver (auxiliary transplanta- 



95 



Vol. 2, No. 5, 1982 



EVOLUTION OF LIVER TRANSPLANTATION 



633 



tion) without removal of the diseased native organ. Clin- 
ical trials have been discouraging, as summarized by 
Fortner et al. (136) from the compiled world experience. 
Of nearly 50 well-documented auxiliary transplantations, 
only one was an unequivocal success. Subsequently a 
report from Paris described a second success (137). 

Our opinion has been that auxiliary liver transplanta- 
tion should be restricted to patients with potentially 
reversible liver disease. In such a situation, the extra liver 
could be construed as a temporary support organ which 
can be removed later. However, we have encountered 
increasing numbers of patients whose portal vein has 
clotted in the hepatic hilum, making it technically im- 
possible to consider liver replacement. Other candidates 
are those with extensive previous surgery in the right 
upper quadrant. Such patients can theoretically be 
helped by an auxiliary liver transplantation, particularly 
when the superior mesenteric vein or other distal tribu- 
tories to the main portal circulation are still open. The 
optimal conditions for vascularization of an auxiliary 
liver graft require input from the portal circulation (2, 
32, 138, 139), largely because of its high concentrations of 
endogenous hormones. 

DETERMINANTS OF THE FUTURE 
The Question of Financing 

Through 1980 in the United States, almost all liver 
transplantations were performed in the Clinical Research 
Centers (CRC) supported by the National Institutes of 
Health. The fraction of the per case cost born by this 
government agency shrank from year to year because of 
the increasing willingness of many third party insurance 
carriers to pay for part or all of the service. Third party 
payments were collected by the institution and remanded 
back to the National CRC headquarters which included 
such collections as part of the total grant funding. In the 
last years of the program at the University of Colorado, 
approximately 85% of CRC expenditures for liver trans- 
plantation were paid for in this way. By having CRC 
support for the other 15%, it was not necessary to screen 
candidates for their ability to pay. This creative practice 
of federal and private cost sharing was conceived and 
made practical by Dr. William DeCaesare, Director of 
the Clinical Research Center Division, Bethesda, Md. 
Thanks to the administrative leadership that flowed from 
DeCaesare's office for more than 2 decades, almost all 
modern-day techniques of immunosuppression and 
transplantation of all organs, beginning with the kidney, 
were developed on CRC units. 

However, it is not reasonable to look indefinitely to the 
CRC for support. So far, none of the liver recipients at 
the University Health Center of Pittsburgh has been 
treated on the pediatric or adult CRC. The principal 
financing for their care has been from health insurance 
programs or, less commonly, from private sources includ- 
ing community fund raising. The collection rate for bills 
has been greater than in the Colorado experience. With 
the exception of Blue Cross/Blue Shield and some health 
maintenance organization programs, the major health 
insurance companies have willingly accepted their re- 



sponsibility for liver transplant candidates providing they 
were forewarned. The patterns of support from Blue 
Cross/Blue Shield have been irregular, probably because 
of their close association with MediCare. 

It is ironic that government decisions or opinions have 
impeded the movement of liver transplantation to the 
private sector of medicine. A pronouncement by a state 
or federal official of MediCare to the effect that liver 
transplantation is "experimental" and not fundable has 
often been the basis for a similar decision by regional 
officials of Blue Cross and/or Blue Shield or by a cost- 
conscious health maintenance organization. Even so, a 
rapidly growing number of state (or Blue Cross) agencies 
(including those in Pennsylvania, New York, and New 
Jersey) have classified liver transplantation as a service. 

In spite of the advantage of a preexisting federally 
funded organ procurement network in the United States 
as part of the End Stage Renal Disease Program, the 
financing of liver procurement is not on a solid base. 
There are no formal guidelines about how to proportion 
the extra costs of removing extrarenal organs from a 
multiple organ donor, or how to ensure against the po- 
tential malpractice and other liability that could be in- 
curred. Etna Life Insurance Company, the carrier for the 
National Kidney Procurement Program, recently drew 
attention to these policy gaps in a document that had a 
chilling effect on some transplant coordinators. 

The approximate average cost of a liver transplanta- 
tion in Pittsburgh has been $55,000 (range $23,000 to 
$150,000). The procedure offers hope of genuine rehabil- 
itation. Dying of endstage liver disease with no hope of 
real recovery may be even more expensive. O'Donnell et 
al. (140) reported from Boston that the average cost of 
nonsurgical treatment of patient for variceal hemorrhage 
was $35,000. The use of any operative procedure in- 
creased the total to $53,000. In many of our patients, the 
expenses incurred during repeated hospitalizations before 
transplantation dwarfed those incurred by transplanta- 
tion itself. 

The Potential Influence of Transplantation 
Upon the Practice of Hepatology 

Five to 10 years from now, we believe that every major 
center for the treatment of liver disease will have either 
transplantation capabilities or direct access to this kind 
of service. The surgical techniques are within the grasp 
of many practicing surgeons. The frequency with which 
liver transplantation can be used will be great although 
this has not been properly assessed. Our estimate is that 
at least 20 centers will be required in the United States. 

Knowledge that the provision of new liver tissue is a 
realistic objective at the end of the line will influence 
decisions about treatment. It will be increasingly impor- 
tant to avoid major and often futile surgical operations 
that jeopardize ultimate candidacy for transplantation. 
Fortunately, there are alternative approaches. Sclerosing 
therapy for the control of variceal hemorrhage instead of 
portal diversion has become increasingly accepted. 
"Interventional radiologists" often have been able to 
ameliorate duct strictures in sclerosing cholangitis and 



96 



634 



STARZL ET AL. 



Hepatology 



other diseases as effectively as can surgeons at open 
operation. When procedures such as porticoenterostomy 
(Kasai) are performed in infants with biliary atresia, it 
will be worthwhile to avoid deviations from the standard 
Roux-Y technique and multiple reoperations which make 
transplantation difficult or impossible. 

The presence of regional units undoubtedly will move 
the timing of transplantation forward in the course of the 
disease The fact that there has been a very high preop- 
erative mo>: '.lity of patients accepted as candidates for 
new livers is an indication of the lateness of referrals. 
Throughout the years, many others have reached the 
operating room in such appalling condition that there 
was little hope of survival. 

An avalanche of new scientific information should 
become available to hepatologists and surgeons as the 
result of progress in transplantation. Much has already 
been learned about the synthesis of proteins whose origin 
was not previously clear (2, 9, 141-143). Further improve- 
ments in surgical techniques and immunosuppression 
will increase the harvest. The history of medicine is that 
what was inconceivable yesterday and barely achievable 
today often becomes routine tomorrow. 
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35. Starzl TE, Marchioro TL. Faris TD, et al. Avenues of future 
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erence to hepatic supportive procedures, antilymphocyte serum, 
and tissue typing. Am J Surg 1966; 112:391-400. 

36. Starzl TE, Marchioro TL, Porter KA et al. The use of heterolo 
gous antilymphoid agents in canine renal and liver homotrans- 
plantation and in human renal homotransplantation. Surg Gyne- 
col Obstet 1967; 124:301-318. 

37. Mikaeloff P, Pichlmayr R, Rassat JP, et al. Orthotopic homotrans- 
plantation of the liver in the dog: immunosuppressive treatment 
with antilymphocyte serum. Presse Med 1967; 75:1967-1970. 

38. Birtch AG, Orr WM, Duquella J. Evaluation of horse anti-dog 
antilymphocyte globulin in the treatment of hepatic allografts. 
Surg Forum 1968; 19:186-188. 

39. Starzl TE, Porter KA, Putnam CW. Eleven and two-thirds years 
survival after canine orthotopic liver transplantation. Transplan- 
tation 1977; 23:168-171. 

40. Gamier H, Clot JP, Bertrand M, et al. Liver transplantation in 
the pig: surgical approach. C R Seances Acad Sci (Paris) 1965; 
260:5621-5623. 

41. Peacock JH, Terblanche J. Orthotopic homotransplantation of 
the liver in the pig. In: Read AE, ed. The liver. London: Butter- 
worth * Co., Ltd.. 1967: 333-336. 

42. Calne RY, White HJO, Yoffa DE. et al Prolonged survival of liver 
transplants in the pig. Br Med J 1967; 4:645-648. 

43. Starzl TE, Porter KA, Putnam CW, et al. Orthotopic liver trans- 
plantation in 93 patients. Surg Gynecol Obstet 1976; 142:487-505. 

44. Starzl TE, Schneck SA. Mazzoni G, et al. Acute neurological 



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EVOLUTION OF LIVER TRANSPLANTATION 



635 



complications after liver transplantation with particular reference 

to intraoperative cerebral air embolus. Ann Surg 1978; 72 

187:236-240. 

45. Starzl TE, Koep LJ. Halgrimson CG, et al. Fifteen years of clinical 
liver transplantation. Gastroenterology 1979; 77:375-388. 73 

46. Starzl TE, Koep LJ. Weil R, III. et al. Development of a supra- 
hepatic recipient vena cava cuff for liver transplantation. Surg 
Gynecol Obstet 1979; 149:76-77. 

47. Calne RY. Surgical aspects of clinical liver transplantation in 14 74 
cases. Br J Surg 1969; 56:729-736. 

48. Calne RY. A new technique for biliary drainage in orthotopic liver 
transplantation utilizing the gallbladder as a pedicle graft conduit 75 
between the donor and recipient common bile ducts. Ann Surg 
1976; 184:605-609. 

49. Calne RY. Williams R. Orthotopic liver transplantation: the first 76 
60 patients. Br Med J 1977; 1:471-476. 

50. Calne RY. McMaster P, Portmann B, et e\. Observations on 
preservation, bile drainage and rejection. Ann Surg 1977; 77 
186:282-290. 

51. Calne RY, Williams R. Liver transplantation. Curr Probl Surg 
1979; 16:3-44. 78 

52. Calne RY, McMaster P, Smith DP, et al. Use of partial cardio- 
pulmonary bypass during the anhepatic phase of orthotopic liver 
grafting. Lancet 1979; 2:612-614. 79 

53. Calne RY, Williams R, Lindop M, et al. Improved survival after 
orthotopic liver grafting. Br Med J 1981; 283:115-118. 

54. von Kaulla KN, Kaye H. von Kaulla E, et al. Changes in blood 80 
coagulation before and after hepatectomy or transplantation in 

dogs and men. Arch Surg 1966; 92:71-79. 81. 

55. Groth CG, Pechet L. Starzl TE. Coagulation during and after 
orthotopic transplantation of the human liver. Arch Surg 1969; 82. 
98:31-34. 

56. Iwatsuki S, Popovtzer M, Corman J, et al. Recovery from 
"hepatorenal syndrome" after orthotopic liver transplantation. N 

Engl J Med 1973; 289:1155-1159. 83. 

Benichou J, Halgrimson CG, Weil R, III, et al. Canine and human 
liver preservation for 6-18 hours bv cold infusion. Transplantation 
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58. Wall WJ, Calne RY. Herbertson BM. et al. Simple hypothermic 
preservation for transporting human livers long distances for 
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59 Shaw BW. Jr., Hakala T. Rosenthal JT, et al. Combination donor 

hepatectomy and nephrectomy and earlv function results of alio- 86. 
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alterations caused during orthotopic liver transplantation in hu- 
mans. Surgery 1971; 70:872-875. 

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the need for venous decompression during the anhepatic phase of 
canine orthotopic liver transplantation. Surgery 1970; 67:319-321. 

62. Martineau G. Porter KA, Corman J. et al. Delayed biliary duct 
obstruction after orthotopic liver transplantation. Surgery 1972; 89. 
72:604-610. 

63. Starzl TE, Porter KA. Putnam CW. et al. Biliary complications 
after liver transplantation: with special reference to the binary 90. 
cast syndrome and techniques of secondary duct repair. Surgery 
1976;81:213-221. 

64. Terblanche J. Koep LJ. Starzl TE. Liver transplantation. Med 91. 
Clin North Am 1979; 63:507-521. 

65. Waddell WR, Grover FL. The gallbladder as a conduit between 

the liver and intestine. Surgery 1973; 74:524-529. 92. 

66. Iwatsuki S. Iwaki Y. Kano T, et al. Successful liver transplantation 
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67. Starzl TE. Experience in renal transplantation. Philadelphia: W. 
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68. Murray JE, Merrill JP. Dammin GJ, et al. Study on transplanta- 94. 
tion immunity after total body irradiation: clinical and surgical 
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57 



61 



69 



70 



in man in modified recipients. Ann Surg 1963; 158:608-644. 
Murray JE, Merrill JP, Harrison JH, et al. Prolonged survival of 
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Woodruff MFA, Robson JS. Nolan B. et al. Homotransplantation 
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Opelz G. Mickey MR. Terasake PI. HLA matching and cadaver 
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McDonald JC, Vaughn W. Filo RS, et al. Cadaver donor renal 
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Starzl TE. Putnam CW Halgrimson CG, et al. Cyclophosphamide 
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Franksson C. Survival of homografts of skin in rats depleted of 
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Starzl TE. Weil R. III. Koep LJ. et al. Thoracic duct drainage 
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Starzl TE, Klintmalm GBG. Iwatsuki S, et al. Late follow-up after 
thoracic duct drainage in cadaveric renal transplantation. Surg 
Gynecol Obstet 1981; 153:377-382. 

Starzl TE. Koep L. Porter KA, et al. Decline in survival after liver 
transplantation. Arch Surg 19H0; 115X15-819. 
Strober S, Slavin S, Fuks Z. et al. Transplantation tolerance after 
total lymphoid irradiation. Transplant Proc 1979; 11:1032-1038. 
Najarian JS. Sutherland DER. Ferguson RM, et al. Fractional 
total lymphoid irradiation <TLI) as preparative immunosuppres- 
sion in high risk renal transplantation. Ann Surg 1982; 196:442- 
452. 

Boret JF, Feurer C. Gubler HU, et al. Biological effects of cyclo- 
sporin A; a new antilvmphocvtic agents. Agents Actions 1976; 
6:468-475. 

Borel JF, Feurer C, Magnee C. et al. Effects of the new anti- 
lvmphocytic peptide cyclosporin A in animals. Immunology 1977; 
32:I017-i025. 

Kostakis AJ. White DJG. Calne RY. Prolongation of rat heart 
allograft survival by cyclosporin A. IRCS Med Sci 1977; 5:280. 
Calne RY, White DJG. Cyclosporin A: a powerful immunosup- 
pressant in dogs with renal allografts. IRCS Med Sci 1977; 5:595. 
Calne RY, White DJG. Rolles K. et al. Prolonged survival of pig 
<>] i hot. >jii( heart grafts treated with cyclosporin A. Lancet 1978; 
1:1183-1185. 

Calne RY. White DJG. Pentlow BD, et al. Cyclosporin A: prelim- 
inary observations in dogs with pancreatic duodenal allografts and 
patients with cadaveric renal transplants. Transplant Proc 1979; 
11:860-864. 

Green CJ, Allison AC. Extensive prolongation of rabbit kidney 
allograft survival after short-term cyclosporin A treatment. Lancet 
1978; 1:1182-1183. 

Calne RY, White DJH, Thiru S. et al. Cyclosporin A in patients 
receiving renal allografts from cadaver donors. Lancet 1978; 
2:1323-1327. 

Calne RY. Rolles K, White DJG, et al. Cyclosporin A initially as 
the only immunosuppressant in 34 patients of cadaveric organs; 
32 kidneys, 2 pancreases, and 2 livers. Lancet 1979; 2:1033-1036. 
Starzl TE. Weil R. Ill, Iwatsuki S. et al. The use of cyclosporin A 
and prednisone in cadaver kidnev transplantation. Surg Gynecol 
Obstet 1980; 151:17-26. 

Starzl TE. Klmtmalm GBG. Weil R. III. et al. Cyclosporin A and 
steroid therapy in 66 cadaver kidney recipients. Surg Gynecol 
Obstet 1981; 153:486-494. 

Calne RY. White DJG. Evans DB, et al. Cyclosporin A in cadav- 
eric organ transplantation. Br Med J 1981; 282:934-936. 
Carpenter BJ, Tilney NL. Strom TB. et al. Cyclosporin A in 
cadaver renal allografts Kidney Int 1981; 19:265. 
Sweny P. Farrington K, Younis F. et al. Sixteen months experience 
with cyclosporin A in human kidnev transplantation. Transplant 
Proc 1981; 13:365-367. 

Starzl TE, Hakala TR, Rosenthal JT, et al. Variable convalescence 
and therapy after cadaveric renal transplantation under cyclo- 



98 



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sponn A and steroids. Surg Gynecol Obstet 1982; 154:819-825. 
Powles RJ, Clink HM, Spence D. Cyclosporin A to prevent graft- 
versus-host disease in man after allogenic bone-marrow transplan- 
tation. Lancet 1980; 1:327-329. 

Klintmalm GBG, Iwatsuki S, Starzl TE. Nephrotoxicity of cyclo- 
sporin A in liver and kidney transplant patients. Lancet 1981; 
1:470-471. 

Keown PA, Stiller CR, Ulan RA. et al. Immunological and phar- 
macological monitoring in the clinical use of cyclosporin A. Lancet 
1981; 1:686-689. 

Rynasiewicz JJ, Sutherland DER, Simmons RL. et al. Cyclosporin 
A for the oliguric renal transplantation patient. Lancet 1981; 1:276. 
Kahan BD, Van Buren CT. Lin SN, et al. Immunopharmacologic 
monitoring of cyclosporin A treated recipients of cadaveric kidney 
allografts. Transplantation 1982; 34:36-45. 

Klintmalm GBG. Iwatsuki S, starzl 1 1. cyclosporin rt neuauiioA- 
icity in 66 renal allograph recipients. Transplantation 1981; 
32:488-489. 

Penn I. Tumor incidence in human allograft recipients. Transplant 
Proc 1979; 11:1047-1051. 

Starzl TE, Groth CW, Putnam J, et al. Cyclophosphamide for 
clinical renal and hepatic transplantation. Transplant Proc 1973; 
1:511-516. 

Calne RY, Rolles K. White DJG, et al. Cyclosporin A in clinical 
organ grafting. Transplant Proc 1981, 13:349-358. 
Starzl TE. Iwatsuki S, Klintmalm G, et al. Liver transplantation 
1980, with particular reference to cyclosporin A. Transplant Proc 
1981; 13:281-285. 

Starzl TE, Klintmalm GBG. Weil R. Ill, et al. Liver transplanta- 
tion with use of cyclosporin A and prednisone. N Engl J Med 1981; 
305:266-269. 

Starzl TE, Iwatsuki S. Bahnson HB. et al Cyclosporin A and 
steroids for liver and heart transplantation. In: Proceedings of 
International Symposium of Cyclosporin A. Cambridge, England. 
Amsterdam: Elsevier/North-Holland Biomedical Press, 1982. 
Porter KA. Pathology of liver transplantation. Transplant Rev 
1969; 2:129-170. 

Myburgh JA, Abrahams C. Mendelsohn D, et al. Cholestatic 
phenomenon in hepatic allograft rejection in the primate. Trans- 
plant Proc 1971; 3:501-504. 

Limmer J, Herbertson BM. Calne RY. Orthotopic rat liver trans- 
plantation using different combinations of 4 inbred strains. Eur 
Surg Res 1980; 12:343-348. 

Herbertson BM. Pathology of liver transplants. In: Calne RY, ed. 
Clinical organ transplantations. Oxford: Blackwell Scientific Pub- 
lications. 1971. 

Portmann B, Williams R. Histopathology of the transplanted liver. 
In: Williams R, Cantoni L. eds. Recenti progressi in epatologia. 
Milan: Casa Editrice Ambrosiana, 1979:369-381. 
Hunt AC. Pathology of liver transplantation in the pig. In: Read 
AE, ed. The liver. London: Bulterworths, 1967:337-349. 
Fennel! RH, Roddy HJ Liver transplantation: the pathologist's 
perspective. Pathol Ann 1979; 14(Part 21:155-182. 
Andres GA, Accini L. Ansell ID, et al Immunopathologic studies 
of orthotopic human liver allografts. Lancet 1972; 1:275-280. 
Brettschneider L, Tong J, Boose DS, et al. Specific bacteriologic 
problems with canine orthotopic liver transplantation. Arch Surg 
1968; 97:313-322. 

Fulginiti VA, Scribner R, Groth CG, et al. Infections in recipients 
of liver homografts. N Engl .1 Med 1968; 279:619-626. 
Schroter GPJ, Hoelscher M, Putnam CW. et al. Infections com- 
plicating orthotopic liver transplantation: with emphasis on graft 
related septicemia. Arch Surg 1976; 111:1337-1347. 
Schroter GPJ, Hoelscher M, Putnam CS, et al. Fungus infections 



after liver transplantation. Ann Surg 1977; 186:115-122. 
122 Calne RY Liver transplantation for liver cancer. World J Surg 
1982; 6:76-80. 

123. Starzl TE, Putnam CWK, Ishikawa M, et al. Current policies in 
hepatic transplantation: candidacy of patients with alcoholic liver 
disease or preformed antidonor antibodies and a reappraisal of 
biliary duct reconstruction. N Y Acad Sci 1975; 252:145-158. 

124. Iwatsuki W. Klintmalm GBG, Starzl TE. Total hepatectomy and 
liver replacement (orthotopic liver transplantation) for primary 
hepatic malignancy. World J Surg 1982; 6:81-85. 

125. Craig JR, Peters RL, Edmondson HA, et al. Fibrolamellar carci- 
noma of the liver: a tumor of adolescents and young adults with 
distinctive clinico-pathologic features. Cancer 1980; 46:372-379. 

126. Berman MM, Libbey NP, Foster JH. Hepatocellular carcinoma; 
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a favorable prognosis. Cancer 1980; 46:1448-1455. 

127. Dubois RS, Giles G, Rodgerson DO, et al. Orthotopic liver trans- 
plantation for Wilson's disease. Lancet 1971; 1:505-508. 

128. Groth CG, Dubois RS, Corman J. et al. Metabolic effects of 
hepatic replacement in Wilson's disease. Transplantation Proc 
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129. Putnam CW, Porter KA, Peters RL, et al. Liver replacement for 
alpha- 1 -antitrypsin deficiency. Surgery 1977; 81:258-261. 

130. Hood JM, Koep LJ, Peters RL, et al. Liver transplantation for 
advanced liver disease with alpha- 1 -antitrypsin deficiency. N Engl 
J Med 1980; 302:272-275. 

131. Fisch RO, McCabe ERB, Doeden D, et al. Homotransplantation 
of the liver in a patient with hepatoma in hereditary tyrosinemia. 
J IVdiatr 1978;93:592-596. 

132. Starzl TE, Iwatsuki S, Malatck JJ, et al. Liver and kidney trans- 
plantation in children under cyclosporin A and steroids. J Pediatr 
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133 Corman JL, Putnam CW, Iwatsuki S, et al. Liver homotransplan- 
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134. Johnson PJ, Wansbrough-Jones MH, Portmann B, et al. Familial 
HBsAg positive hepatoma: treatment with orthotopic liver trans- 
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136. Fortner JG, Yeh SDJ, Kim DK, et al. The case for and technique 
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138 Marchioro TL. Porter KA. Dickinson TC, et al. Physiologic re- 
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99 

Mr. Gore. Dr. G. Melville Williams, in addition to being profes- 
sor of surgery at Johns Hopkins Hospital and a distinguished sur- 
geon, is president of the American Society of Transplant Surgeons. 

Dr. Williams, you, too have gone to a special extreme to be with 
us today, rearranging your travel plans to Holland where you were 
scheduled to appear before the International Congress on Organ 
Procurement today. We appreciate the extra effort, and we look 
forward to your testimony. 

Dr. G. Melville Williams. Thank you, Mr. Gore. 

It is possible to summarize national efforts in kidney transplan- 
tation using round numbers, which are easier to remember some- 
what more than 5,000 kidney transplants were performed last year; 
of these, 30 percent of the kidneys came from related living donors; 
3,300 kidneys can be expected to provide life-sustaining function; 
2,500 individuals may be expected to return to work or to premor- 
bid social activity; and, soberingly, 500 individuals die. 

The key point is that through kidney transplantation with exist- 
ing knowledge, one-half of the individuals transplanted return to 
work, or their state of health before they got sick. 

The analysis of data acquired by many collaborating centers 
show that five variables have influenced the degree of success. 
These variables are the center — some centers have excellent results 
and some not so good — second is the number of blood transfusions 
given the perspective recipient prior to transplantation; third is the 
use of antilymphcitic serum; fourth, whether or not the kidney 
functions immediately after transplantation; and fifth, the degree 
of matching of donor and recipient. Knowledge of the influence of 
these factors has been harnessed by most transplantation centers 
with an improved overall national success rate increasing from 48 
percent to close to 60 percent in the past year in organs recovered 
from cadaver donors. 

It is interesting to note at this point that what has been consid- 
ered traditionally as a therapeutic endeavor, namely kidney trans- 
plantation, reports results that are inferior to the results reported 
by Dr. Shumway for heart transplantation, and slightly inferior to 
the results that Dr. Starzl has published on liver transplantation. 
It should be acknowledged that, in kidney transplantation, we 
have, except for four centers, been unable to use the immuno- 
suppressive agents available for use in these nonrenal transplants. 
The point is that we have to redefine our concepts of what is ex- 
perimental and what is not. 

In the past, there has been some concern that patients with 
kidney failure were denied access to transplantation systems. Vir- 
tually all patients enter the system after having their lives sus- 
tained by dialysis. Thus, referral to a transplant center is entirely 
dependent upon the perception on the part of the patient and the 
nephrologist caring for him that transplantation offers distinct ad- 
vantages. With results improving and with the prospect of a real 
breakthrough in the near future, this problem, I believe, will be 
diffused and unimportant. Patients awaiting transplantation are 
registered with the transplant center and undergo tissue typing 
and screening for the presence of antibodies in their serum. The 
presence of these antibodies informs the transplant surgeon that 
the patient has had exposure to human tissues and has developed 



100 

some immunity to them through blood transfusions, pregnancies, 
or other transplants. 

Four centers in this country have had experience with the new 
immunosuppressive agent, cyclosporine, in attempts to suppress re- 
jection in renal allografts. All investigators agree that many of the 
practices we have applied may prove to be obsolete when this drug 
becomes available for general use, hopefully by the end of June or 
the first part of July. This drug, used in combination with small 
doses of Prednisone, promises to provide us with 80 to 90 percent 
rates of success in cadaver donor transplants. The early concerns 
about the development of cancer and of the potential toxicity of the 
drug to the kidney itself have been ameliorated to some extent by 
more recent experience. 

Thus, the field of kidney transplantation is excited and restless 
awaiting the availability of cyclosporine. As a nation, it behooves 
us to plan our national strategy. I foresee four major problems con- 
fronting us. First, research funding; second cost containment; third, 
data acquisition and analysis; and fourth, increasing the rate of 
organ donation — the fourth being the most significant. 

It may be surprising to some of you in this room to know that we 
are considerably behind our European colleagues in the application 
of a crucial histocompatibility locus in tissue typing. It may be dis- 
concerting to know that we do not know how to characterize our 
black patients in terms of their tissue typing makeup nearly as 
well as we how to characterize our Caucasian patients. Further, if 
we could reliably preserve livers, lungs, hearts, for a period of 12 to 
24 hours, considerable savings could be achieved in eliminating the 
need for charter jet travel between the city identifying a heart or 
liver donor and the transplantation center. 

With respect to the kidney itself, where most of us feel the pres- 
ervation problems are pretty well solved there is in fact the reality 
that 25-45 percent of the kidneys transplanted fail to function im- 
mediately—and this may be a very important point when using the 
new agent cyclosporine — it has some deleterious effects on the 
kidney — so without a monitor of toxicity, that is, some baseline 
renal function, our success rates may well be jeopardized. 

I wish to address the problem of cost and make two points. First, 
there is the widespread notion which I think we should roundly 
defeat that any new therapy is apt to be costly therapy. Regretta- 
bly, this may be true in some instances, but in many others, this is 
a very short-sighted view. As Dr. Starzl has already pointed out, 
the treatment that we commonly give patients with liver failure 
may be more expensive than the process that cures them. 

In the case of transplantation, there was a recent directive from 
the Health Care Financial Administration that it would not pay for 
purposeful blood transfusions between a potential living donor and 
the potential recipient of the kidney, a process which has led to 90 
percent graft success, even in mismatched donor-recipient pairs. 
The cost of giving the blood transfusion is one-third the cost of one 
dialysis treatment. 

Support must be given to agencies such as the Office of Technol- 
ogy Assessment to develop a much more reasoned approach in our 
application and evaluation of new methods of therapy and means 
of financial reimbursement in this whole field of transplantation. 



101 

The second point regarding cost and transplantation is that, 
purely in economic terms, long-term disability associated with ex- 
pensive therapy costs more than death, which costs more than a 
cure. One can do some simple calculations regarding the expendi- 
tures required to sustain a disabled individual on hemodialysis. 
We, the taxpayers, pay for the medical therapy and the social secu- 
rity benefits accrued to the individual. We also lose taxes from the 
loss of income. In the event of death, we are faced with paying 
social security death benefits and we lose income from taxes. But 
in the case of cure, we pay for medical therapy alone and recover 
money from taxes in gainful employment. 

As academicians, we commonly view our substantial rate of fail- 
ure in kidney transplantation as the principal cost. However, re- 
cently, Dr. Krakauer, in analysis of data at the NIH, has shown 
through mathematical models that even if we increased the rate of 
success of cadaver transplantation to 90 percent, we will do very 
little to reduce overall costs of treating the patient with kidney 
failure because the costs are principally related to chronic hemo- 
dialysis. The only way costs can be substantially reduced nation- 
wide is to increase the number of transplants performed, and I 
would suggest that a target goal would be to double the number of 
transplants in the next 5 years. 

As we are now poised to enter a new era in clinical transplanta- 
tion, it is important to know on a timely basis how we are perform- 
ing. Despite the carefully conducted trials with cyclosporine, diffi- 
culties may be encountered which are entirely unexpected. Our 
current system of acquiring data — and this may help with the ques- 
tion raised by our Congressman — is to obtain it from the transplant 
centers via the networks that then forward the verified data to the 
Medical Information System within the Health Care Financing Ad- 
ministration. I have worked with this group. They are intelligent, 
interested, highly-informed and hard-working people. 

But those that are required to collect the data and assess it are 
poorly supported monetarily. For example, any form that is distrib- 
uted as a questionnaire to gain information must be processed 
through OMB. This takes time. And any correction of that form, 
such as searching for new toxicities related to cyclosporine, for ex- 
ample, must go through the same process. So, between the time we 
ask the question and get the answer, an enormous period has 
lapsed and there will be no way to generate data on a national 
scale without creating, I think, legislatively some funds to support 
this either within the government or arranging contracts to inde- 
pendent and interested individuals, such as Dr. Paul Tarasaki who 
has maintained an ad hoc registry without due reimbursement for 
long periods of time. 

Lastly, and most importantly, there is this problem of increasing 
the number of transplants performed. There has been a steady in- 
crease, as I mentioned, from 4,721 transplants 4 years ago, to 5,358 
in 1982. However, this trend cannot possibly meet the demand cre- 
ated by improved results. 

At one time — and I guess this was about 15 years ago — a study 
was done which estimated that 50,000 individuals might die in the 
United States each year at any age and of a disease compatible 
with organ donation. A more recent conservative estimate places 



102 

this figure at 20,000. This is still immaterial, considering that only 
2,000 become actual kidney donors. Is the reason for our failure to 
obtain more organs the result of negative public attitudes or ineffi- 
cient procurement systems? I think both. 

With respect to attitudes, virtually every poll has indicated that 
the majority of the American people are willing to donate parts of 
, their body for transplantation if the results are good. However, the 
mechanisms for opting into the system of organ donation are suffi- 
ciently complex that, for example, in the State of Maryland, one 
has to have two witnesses in order to sign an organ donor card to 
put on your driver's license. At least 98 percent of the people re- 
quested to do so have failed to sign up as organ donors. We have 
never been called in a single instance from any emergency room in 
which they have identified an individual with a card on their 
person and asked us to proceed with organ removed for transplant. 
From the organ procurement systems point of view, the decision 
for organ donation is requested at the wrong time. When death is 
sudden and accidental, there may be no time to locate and ap- 
proach the family and no organs are removed. In a great majority 
of instances, a family confronted with grief is asked to make an- 
other contribution, and 30 to 75 percent of the families, when re- 
quested, say no. 

The role of the Government is, I think, very complex and contro- 
versial. In a sense, we as a society have deemed that all patients 
having kidney failure may be treated, and we pay for it. It is also 
likely that the best treatment is kidney transplantation. Yet, while 
all individuals would favor this type of therapy for themselves, we 
consider attitudes favorable toward transplantation if a mere bO 
percent canvassed state that they are favorably included toward 
organ donation. It is what I call the "Henny-Penny syndrome, 
where everybody wants to eat the bread and nobody wants to plant 
the wheat. In the particular case of organ transplantation and 
organ donation, the decision, pro or con, has to be made by individ- 
uals at some point removed from the immediate grief of the cir- 

PllTYlstflLTlC^S OT Q.63.LX1 

If it is in the best interest of society to obtain the bullet in order 
to find the murderer, I might ask, is it not also in the best interest 
of society to obtain kidneys, hearts, livers, and pancreases to save 
the lives and relieve the suffering of other individuals? In the case 
of the bullet, the family has no option to deny autopsy and dis- 
memberment. In the case of the heart and the liver and the lung, 
the family persists in having the right, and we would defend that 
right. But you see how discrepant we are in our circumstances. 

Most recently in California, a law was passed which I hope re- 
ceives due attention, and that is that, in cases that would come to 
autopsy by the coroner or medical examiner, the coroner would be 
empowered to remove the cornea unless there was expressed dis- 
sent. So, from the ethical point of view— and I should add that sim- 
ilar laws are present in Maryland, Florida and West Virginia. 
(Maryland was the first State to pass such a law, I believe). The 
decision has been made in favor of presumed consent. Yet, it we 
were to proceed with this, normally I think it would shell shock 
our Nation. So we have to proceed cautiously. 



103 

In Colorado, a State law exists demanding an individual to say 
yes or no at the time of applying or renewing a driver's license. 
The individual cannot ignore the question, I believe. So there is co- 
ercion brought to bear on making the decision. At this stage, this 
would be all, I think, that society would be willing to go with, and I 
suggest simply that everybody think about this and make a deci- 
sion for their own personal use in writing to have on their person. 

In conclusion, I want to just make three points: The results of 
kidney transplantation are improving and will improve further; 
there is still the need for research, particularly in the field of 
organ preservation; and a breakthrough is necessary for organ do- 
nation to be viewed as normal and natural by the public. When 
this occurs, we can truly celebrate a new era. 

Thank you. 

[The prepared statement of Dr. G. Melville Williams follows:] 



104 

KIDNEY TRANSPLANTATION 1982 
THE STATE OF THE ART AWAITING A BREAKTHROUGH 

It is possible to summarize national efforts in kidney transplantation 
using round numbers as follows: somewhat more than 5,000 kidney transplants 
are performed per year; of these, 30% of the kidneys come from related living 
donors; 3,300 kidneys can be expected to provide life sustaining function; 
2,500 individuals may be expected to return to work or to premorbid social 
activity; and 500 individuals die. 

The analysis of data acquired by collaborating centers show that five 
variables influence the degree of success. These variables are: the center 
performing the transplant; the number of transfusions given the perspective 
recipient prior to transplantation; the use of antilymphocytic serum to 
augment immunosuppressive treatment; the degree of matching of donor and 
recipient; and whether or not the kidney functions immediately after trans- 
plantation. Knowledge of the influence of these factors has been harnessed 
by most transplantation centers with an improved overall national success rate 
increasing from 48% to close to 60% for cadaver donor kidneys. 

In the past there has been concern that some patients with kidney 
failure were denied access to the transplantation system. Virtually all 
patients enter the system after having their lives sustained by dialysis. 
Thus, referral to a transplant center is entirely dependent upon the perception 
on the part of the patient and the nephrologist caring for him that trans- 
plantation offers distinct advantages. With results improving and with the 
prospect of real breakthrough in the near future, this problem, I believe, 
will be diffused. Patients awaiting transplantation are registered with the 
transplant center and undergo tissue typing and screening for the presence of 



105 



antibodies in their serum. The presence of these antibodies informs the 
transplant surgeon that the patient has had exposure to human tissues 
and has developed some immunity to them through blood transfusions, pregnancies, 
or other transplants. 

There is great variation in the organization of transplant centers. 
Historically, transplantation was an acknowledged experimental procedure which 
could be performed only in hospitals affiliated with strong university programs. 
In a given metropolitan area in the east, there may be four or five active 
transplant centers vying for the treatment of patients. In other areas par- 
ticularly in the mid and far west, there may be only one transplant center 
providing services to an enormous population. The location of the center 
and how crowded it is with other centers determine practices and the need for 
collaboration. In order to perform transplants, every center must have some 
means of obtaining transplantable organs and of determining the degree of 
match and the likelihood of success if a given organ is used for a given 
patient. If a center is treating 600 dialysis patients awaiting transplantation, 
clearly it can develop efficient organ procurement programs, tissue typing 
laboratories, community education programs, etc. If a transplantation center 
is serving the needs of 100 patients awaiting transplantation, it must 
affiliate with other centers, for the kidneys it obtains are frequently incompatible 
with its own patients. 

Four centers in this country have had experience with the new immuno- 
suppressive agent, Cyclosporine, and all of these investigators agree that 
many of the practices we have applied may prove to be obsolete when this 
drug becomes available for general use. The drug used in combination with 



106 



small doses of Prednisone promises us with 80 to 90% rates of success in 
cadaver donor transplants. The early concerns about the development of 
cancer in long-term recipients and of the potential toxicity of the drug 
to the kidney itself have been ameliorated to some extent by more recent 
experience. Cyclosporine will not abrogate existing antibody levels 
from previous exposure so that some individuals awaiting transplantation 
may wait long periods of time before a donor is identified to whom the patient 
is not immunized. For these patients and for others who have a concerned 
family member, related living donor transplantation is a valid option. A 
second breakthrough has occurred in this area, namely that of using blood 
drawn from the potential donor given to the potential recipient as a means 
of conditioning the recipient for the kidney transplant. Recipients who have 
sustained three small blood transfusions from their potential donor have 
enjoyed 90% graft survival rates despite being imperfect tissue matches. 
This degree of success has led to greater numbers of volunteer donors and 
may even lead to successful grafts between a husband and a wife, for example. 

Thus, the field of kidney transplantation is excited and restless 
awaiting the availability of Cyclosporine. As a nation, it behooves us to 
plan our national strategy as we apply these technological advances. I 
foresee four major problems confronting us: 1) research funding; 2) cost 
containment; 3) data acquisition and analysis; and 4) increasing the rate of 

organ donation. 

While we anticipate substantial improvement in graft and patient survival 
in the near future, it must be acknowledged that the long-term effects of 
Cyclosporine are not known, and there still must be more precise means for 
controlling the immune response. Basic '"scientists in immunology have developed 



107 



exquisitely specific means for monitoring and controlling some immune 
responses. This technology using monoclonal antibodies has yet to be 
harnessed in clinical transplantation. 

It may be surprising to some to know that we are three years behind 
our European colleagues in attempting to match donor and recipients for the 
Dr antigen system which promises to be more important than the systems 
commonly in practice. We know much less about how to characterize Blacks 
for tissue typing, and we know very little about how to extend the period 
out of the body for organs other than the kidney. If we were able to 
preserve these organs reliably for periods of 12 to 24 hours, considerable 
savings could be achieved by eliminating the need for charter jet travel 
between the city identifying a heart or liver donor and the transplantation 
center. With respect to the kidney itself, much is known about preservation. 
Yet, 25% of cadaver kidneys fail to function immediately after transplantation 
and this is very important when using Cyclosporine. As a nation, we have 
decried the expense of caring for patients with kidney failure while forgetting 
that research and development funds are always necessary to provide better 
solutions. 

The problem of cost containment is one that concerns many of us in 
transplantation and there are two points to be made. First, there is a 
widespread notion that new therapy is costly therapy. Regrettably, this is 
true in many instances, but in many others it is quite short-sighted. For 
example, there was a recent directive from the Health Care Financing Adminis- 
tration that it would not pay for purposeful blood transfusions in the living 
donor situation described. The charge for drawing a unit of blood and dividing 



108 



it into thirds for subsequent transfusion is one-third the charge of one 
dialysis treatment and the result may be a 90% successful outcome of the 
transplant. Support must be given to agencies such as the Office of 
Technology Assessment to develop a reasoned approach in the application 
and evaluation of new methods of therapy and means of reimbursement in the 
field of transplantation. The second point regarding cost and transplantation 
is that in purely economic terms, long term disability associated with 
expensive therapy costs more than death which costs much more than a cure. 
One can do some rather simple calculations regarding the expenditures 
required to sustain a disabled individual on hemodialysis. We, the taxpayers, 
pay for the medical therapy and the social security benefits accrued to the 
individual. We also lose taxes from the loss of income. In the event of 
death, we are faced with paying social security death benefits and we lose 
income from taxes. In the case of cure, we pay for the medical therapy but 
recover money from taxes. 

As academicians, we commonly view our substantial rate of failure as 
the principal cost in transplantation. Recently, Dr. Krakauer at the N.I.H. 
has shown through mathematical models that even increasing the rate of cadaver 
donor transplant success to 90% will do very little to reduce overall costs 
of treating patients with kidney failure. The only way costs can be sub- 
stantially reduced is by increasing the number of transplants performed. 

As we are poised to enter a new era in clinical transplantation, it 
is important to know on a timely basis what our performance is. Despite the 
carefully conducted trials with Cyclosporin, difficulties may be encountered 
which are entirely unexpected. Our current system of acquiring data through 



109 



the End Stage Renal Disease Networks and from the networks into the 
Medical Information System of HCFA is poorly supported. As a group, the 
individuals responsible for the creation of the forms and for their 
collection and analysis are highly motivated, intelligent and hard working. 
Yet, the system lacks monetary commitment and quick response. For example, 
in order to modify the forms and acquire new information regarding Cyclo- 
sporine toxicity, a process involving 0MB must be engineered. One 
recommendation we can all make to this committee is that a stable data 
acquisition and analysis group be formed. This duty can be performed by 
the private sector through contract mechanisms as well as by creating a 
division within a given government agency. 

Finally, there is the problem of increasing the number of transplants 
performed. There has been a rather steady increase over the last four years 
from 4,721 to 5,358. This trend if continued will not meet the demands 
created by improved results. At one time, it was estimated that as many as 
50,000 individuals might die each year at an age and of a disease compatible 
with organ donation. A more recent conservative estimate places this figure 
at 20,000. This is still immaterial considering that only 2,000 become 
actual kidney donors. Is the reason for our failure to obtain more organs 
the result of negative public attitudes or inefficient procurement systems? 
I think both. 

With respect to attitudes, virtually every poll has indicated that the 
majority of the American people are willing to donate parts of their body 
for transplantation. However, the mechanisms for opting into the system 
of organ donation are sufficiently complex that only 2% of the individuals 
given the opportunity at the time of signing their Driver's License in the 



Tl_mo r\ _ ai 



110 



State of Maryland become organ donors. From the organ procurement systems 
point of view, the decision for organ donation must be made at the time of 
death and the decision is made by relatives not the individual. When death 
is sudden and accidental, there may be no time to locate and approach the 
family and no organs are removed. In a great majority of instances, this 
is the wrong time to make a rational decision, and 30-75% of the families 
say no. 

The role of government in altering our system particularly our timing 
to make this important decision of organ donation remains most controversial. 
In a sense, we as a Society have deemed that all patients having kidney 
failure may be treated. It is also likely that the best treatment is kidney 
transplantation. Yet, while all individuals would favor this type of therapy 
for themselves, we consider attitudes favorable toward transplantation if 
a mere 60% canvassed state that they are favorably inclined toward organ 
donation. As a Society, we have denied individuals the right to decline 
autopsy in cases of homocide, suspected suicide and in some accidental deaths. 
If it is in the best interest of Society to obtain the bullet in order to 
find the murderer, is it also not in the best interest of Society to obtain 
kidneys, hearts, livers, pancreas, etc. to save the lives and relieve the 
suffering of other individuals? In certain states, laws have been passed 
enabling the coroner's office to remove the cornea, unless there is expressed 
dissent, for transplantation from bodies that will be autopsied. Thus, we 
are entering into an area where the ethical position has already been 
clarified. What has to happen from now on is a gentle boost in public 
i^nscioucness together with properly timed coercive steps. I have in mind 



Ill 



a goal demanding individuals to state yes or no to organ donation at the 
time they renew their Driver's License without the need for witnesses and 
with full legal recognition that a transplant surgeon may proceed to 
remove organs from an individual carrying a "yes" card without the fear 
of prosecution. 

It is likely that an ever increasing demand for transplantable 
organs will focus public awareness and agreement so that what appears 
to be coercive now will not be in two years. It is my hope that greater 
interest in death and dying and the continuation of life will be addressed 
in medical and pastoral education. Because organ donation is a salutary 
and comforting process for families, it is our obligation to take away the 
agony of the decision at a time of maximal grief and provide them with 
the knowledge that something positive has come from such a tragedy. I 
believe that this will become a new responsibility of every transplant 
service. 

In conclusion, there are three points to be made: 1) the results 
of kidney transplantation are improving and will improve further; 2) there 
is still the need for research, particularly in the field of organ preserva- 
tion; 3) a breakthrough is necessary for organ donation to be viewed as 
normal and natural by the public. When it occurs, we can truly celebrate 
a new era. 



112 

Mr. Gore. Thank you, Dr. Williams. 

I suppose the single most important thing that could be done to 
help solve the problems that you three doctors encounter is for 
American citizens to say to their family members in conversation 
that, "If tragedy ever occurs and I am in a situation where my kid- 
neys or heart or lungs or liver could help someone else to live, I 
would want you, as my next of kin, to make those organs availa- 
ble." Is that the single most important thing that could happen? 
Dr. Shumway. Yes. 
Dr. Starzl. Yes. 
Dr. G. Melville Williams. Yes. 

Mr. Gore. How many lives— let's say, for example, that today or 
tomorrow people in this country had conversations around the 
breakfast table or the dinner table and said to each other, "Look, 
let's agree as a family we think this is important. This will be our 
policy as a family." Let's just imagine that every American in the 
country did that, and you didn't encounter that obstacle, how many 
lives would you estimate you could save as a result? 

Dr. G. Melville Williams. Thousands. If we can raise public 
consciousness to the extent where they make the demands of the 
physician taking care of their loved one during the dying process, 
as is happening — this is beginning now — then we really will have 
made a big step. Part of the problem is the problem with the doctor 
identifying and engaging the donor and the family in the process of 
organ donation, I believe. 

Mr. Gore. So doctors and nurses and hospitals have a role to 
play in making families aware of what the opportunity is for hope 
and joy to be born of tragedy and for them to make available 
organs that are greatly needed to sustain life elsewhere. Do you 
find that many doctors and nurses and hospitals just aren't aware 
of how great this need is? 

Dr. Starzl. I think it is a double problem. I think perhaps the 
doctors and the nurses are aware of it, but it is a kind of a positive 
or affirmative action that can easily be cancelled if the lay public 
doesn't reinforce. And I think it works the other way around, that 
if the lay public will take the first step, then the physicians and 
nurses will reinforce that. But they have to work together. 

This syndrome that has been described of the families demand- 
ing that organs be used and really bringing it up for the first time 
is becoming very common. But I have seen it, going back for 20 
years. It really was how the whole organ donation concept came 
into being in the first place. Interestingly enough, some of the first 
cases that I remember were children of physicians who did not 
want that vital resource to go to waste and having now realized 
that their child was brain dead. 

Mr. Gore. These other problems which we will be attacking are 
likely to have less impact on the solution to the problem, of the 
overall problem, than that raising of awareness among the Ameri- 
can public about how important this is. But they need to be solved, 
too, these other matters, and in the process of solving them, we 
may be able to contribute to making people more aware of how im- 
portant organ donation is. 

Let me just briefly give you my thumbnail understanding of 
what this situation is and ask you to agree or disagree. No. 1, 



113 

through a combination of your skill and the accumulated knowl- 
edge in the medical profession and this remarkable new drug 
called cyclosporine A, which is the latest and most important in a 
series of measures that make rejection almost a thing of the past, 
we have entered a new era of organ transplantation; there is no 
question about that, is there? 

Dr. Starzl. No. 

Dr. G. Melville Williams. No. 

Dr. Shumway. No. 

Mr. Gore. The public is quite aware of the efficacy of kidney 
transplants. But, in fact, Dr. Starzl, there are as many cases of end- 
stage liver disease as there are of end-stage kidney disease — almost 
as many — are there not? 

Dr. Starzl. I think it is in that order of magnitude, or perhaps it 
would be two-thirds as common as end-stage renal disease. But he- 

gatic disease is the fourth leading cause of death in the United 
tates at the present time, or it ranges between third and fifth. 

Mr. Gore. So the potential for the successful procedure you have 
pioneered is equal to the potential — or nearly equal to the poten- 
tial — of kidney transplantation? 

Dr. Starzl. It is going to have a broad application. I don't think 
there is any doubt about it. 

Mr. Gore. Now, the reason the public awareness of liver disease 
does not approach the public awareness of kidney disease is that 
there is no equivalent for dialysis that keeps large numbers of liver 
patients alive for many years, they die if they don't get a trans- 
plant. 

Dr. Starzl. Yes; Mr. Skeen brought back sad memories, as I al- 
ready said, of 20 years ago. In 1962, chronic artificial kidney treat- 
ment was available for six patients in the United States and in the 
world. Those six patients were all at the University of Washington 
under Scribner, where the technology of chronic artificial kidney 
treatment was really just coming out. That is the way things were 
then. But, of course, that changed. 

As Dr. Shumway said, I don't think the prospect of changing 
with hearts or with livers, where the functions are even more com- 
plex, is really a realistic hope for the immediate future, or perhaps 
ever. That means that the urgency for the organs that we are look- 
ing for now is far greater than it is for the kidney, and it will prob- 
ably continue to be that way. 

I think that no renal donor should fail to be considered for the 
need of extra-renal organs on the spot. I think that is an important 
thing, and the transplant coordinating groups, I believe, are really 
working on that. 

Mr. Gore. It is certainly a tragedy that demands a response. 

I wonder if I might just ask people to raise their hands. How 
many parents or close relatives of children in these circumstances 
just heard about these hearings today and came out? Could you 
raise your hands? 

[Show of hands.] 

Mr. Gore. There are several people. I noticed several children in 
the audience. Thank you. 

I know that we have had circulated to us a number of pleas from 
families for assistance from all over this country. 



114 

The label "experimental," isn't accurate when applied to either 
liver transplants or heart transplants; would both of you agree? 

Dr. Starzl. Absolutely. Or heart-lungs. 

Mr. Gore. Let's talk about heart-lungs for a second. The reason 
you transplant the combination of lungs and heart — it is triggered 
by the need to transplant the lungs — but if you transplant the the 
lungs alone, you cannot accurately monitor the onset of rejection. 

Dr. Shumway. Correct. 

Mr. Gore. But by transplanting both the lungs and the heart as 
a system, you can put in a catheter that allows you to monitor and 
control the rejection process and get roughly the same success rate 
as you do with the heart alone; is that correct, Doctor? 

Dr. Shumway. That is correct. 

The X-rays after a lung transplantation are so ambiguous that 
one wouldn't know whether it was rejection or atelectasis or pneu- 
monia or pulmonary edema. But with the heart on the system as 
the monitor of these events, then we can, by taking a little piece of 
the heart out in a very simple manner, look at it under a micro- 
scope, and tell exactly what is going on with respect to the health, 
not only to the heart, of course, but of the lungs as well. So this 
has made the whole thing extremely feasible. I think it has out- 
moded completely any future application of unilateral lung trans- 
plantation. 

Mr. Gore. I see. 

So the label of "experimental" is just inappropriate today? 

Dr. Shumway. I think it is a convenient label to use for anything 
that the third-party carriers or the Government doesn't wish to 
support financially. 

Mr. Gore. Yes. That is laying it on the line, Doctor. 

You said something astonishing in your testimony, that you 
haven't had a single case of rejection? 

Dr. Shumway. Rejection that is notable from the standpoint of 
clinical inspection or examination of the patient. The only way 
with cyclosporine A that we have been able to tell if there is a re- 
jection process going on is through the biopsy of the heart. 

Mr. Gore. I see. That allows you to calibrate the amount of the 
drug that is used. 

Dr. Shumway. Right. And it allows us to intervene at a time 
which is much earlier than in the past, before any severe damage 
to the transplanted organ has occurred. 

Mr. Gore. I understand this drug was discovered by Sandoz Lab- 
oratories having a policy of having its employees bring back soil 
samples from vacations; is that correct? 

Dr. Shumway. That is what I understand, yes. 

Mr. Gore. And one of them came back with a soil sample from 
somewhere in Scandinavia and they ran it through the tests and 
just discovered this in the ground somewhere? 

Dr. Shumway. That is right. Then it was applied experimentally 
in Cambridge, and then clinically as well, and it is now available, 
and I was surprised to hear, in only four renal transplant units. I 
didn't understand that at all. 

Dr. Starzl. In Cambridge, the drug began to be used in the late 
spring or early summer of 1978. It was released in this country to 
the group at Harvard and to us for kidneys in late 1979, and then 



115 

Houston and Minnesota about 9 months after that. So those are 
the four. 

There is a multicenter trial going on in Canada, however, and a 
multicenter trial in Europe, the results of which, in both instances, 
have been reported and showing a marked advantage for the cyclo- 
sporine. 

Mr. Gore. So that has made rejection virtually a thing of the 
past. It still has to be monitored carefully and watched, but, as a 
source of failure, it is virtually a thing of the past. 

Dr. Starzl. It has certainly been enormously reduced. It has just 
about doubled the survival of organs it has been used for. 

Mr. Gore. I know that there are still some questions that have to 
be answered about potential side effects, but this is truly a miracle 
drug and, combined with your magnificent skill and the advances 
in the medical profession generally, we have created — you have 
created — a new era for transplant patients. As you said, Dr. Wil- 
liams, we desperately need a national strategy for coping with the 
onset of a remarkably increased demand for organs for transplan- 
tation, and we have a bioethical imperative to develop such a na- 
tional strategy. 

It is not only bioethics involved, as you know, Dr. Williams, it is 
also cost effective. The NIH has estimated that up to $300 million a 
year, most of it in Federal funds, could be saved if we doubled the 
number of kidneys available for transplantation and equal savings 
could be found from the transplantation of other organs. 

I want to apologize to my colleagues for taking so much time. I 
will come back for more questions on the second round. 

Congresswoman Schneider. 

Mrs. Schneider. Doctors, I am a very strong advocate of preven- 
tion, and I can't help but wonder, since most of our discussions 
have centered around small children and the diagnosis of the liver 
diseases coming something like 2 weeks after birth, is there some 
research, or have we already determined what are the causes of 
the diseases we have been talking about? 

Dr. Starzl. In many of the pediatric diseases, genetic counseling 
might help prevent somebody being born with a genetic taint. The 
fact of the matter is that something like six or seven of these so- 
called in-born errors have now been effectively treated with livers, 
because if the in-born error is a basic enzyme deficiency of the liver 
or hepatic based in other ways, possibly because of enzymes miss- 
ing that you don't even know about, the provision of a new liver 
from a normal person will provide a permanent cure. In other 
words, if you get my liver and you have got some flaw in yours that 
is genetically determined, you will always have the function of my 
liver, and it will make up for what you are missing. But that is cu- 
rative. If you took the same diseases — there are, I think, seven of 
them now that have been treated in this way — it might be possible 
to prevent them. 

The most common pediatric disease is biliary atresia. That is not 
a genetically determined disorder. It is a disease that affects about 
1 — these figures vary somewhat — but perhaps 1 in 8,000 births. I 
calculate it out that, in the United States, that means we are pro- 
ducing about 500 new biliary atresias each year. It is those children 
with biliary atresia who are providing most of these anguished 



116 

calls that you are getting, or many of them. Because they tend to 
be very attractive children, they receive an enormous social eco- 
nomic and medical input and, in the long run, there is no dividend 
unless something decisive can be done. 

But I think that is not a preventable disease. I don't really know 
what causes it. Although there is a lot of speculation about it, I 
don't think there is any information on it. 

Mrs. Schneider. Is there some kind of research going on now 
into the cause? 

Dr. Starzl. I think there is a good deal of research, but there are 
no leads, to my knowledge. 

Just to show you where basic research can sometimes lead, a 
very bright pediatrician named Harvey Sharp at the University of 
Minnesota in 1967 discovered that alpha-1-antitrypsin disease had 
an association with hepatic disease— it was known previously to be 
associated with pulmonary disease. That one little discovery has 
opened up an enormous Pandora's box of new information and has 
made it possible, in some instances, to carry our prophylaxis be- 
cause alpha-1-antitrypsin disease, as it turns out, is one of the lead- 
ing causes of neonatal jaundice. That all has only been known 
since 1967. 

Mrs. Schneider. Part of the reason I am asking is because the 
Science and Technology Committee, of which we are a subcommit- 
tee, has responsibility for the budget of many of the basic research 
programs that are going on, both in the Federal institutions and 
also in many of the universities. 

We have been talking mostly about children and liver trans- 
plants. Are there many adults who are in need of liver trans- 
plants? 

Dr. Starzl. Yes, I think that two-thirds of the candidates, exclud- 
ing the alcoholic population— just the ones that we have been 
about to treat— have been adults. It is a crippling disorder. Alpha- 
1-antitrypsin disease pops up in adult life as well. But I won't ever 
bore you with a list. It is a tedious list of indications or of diseases 
that are nonalcoholic and cause end-stage liver disease. They affect 

people of your age, young people who are vital 

Mrs. Schneider. Flattery will get you everywhere. 
Dr. Starzl. It does affect people in the 20, 30, and 40 age range. 
Our upper limit for liver transplantation in adults has been pretty 
much arbitrarily set at 50 to 55. 

Mrs. Schneider. And it is possible to transplant the liver to a 
person who has alcoholic cirrhosis? 

Dr. Starzl. Yes, without disclosing a name, our longest patient is 
about a decade with alcoholic liver disease, and this was a pretty 
well-known professional football player at one time who has never 
had a drink since that time and has become a major drug abuse 
and alcohol rehabilitation officer in one of the important States. 
Also we did a man who became the chief of an Indian tribe. We did 
him 7 or 8 years ago. 

So I don't think that, out of hand, one can exclude for future con- 
sideration alcoholics. We already know that the incidence of recidi- 
vism is rather small in people, even people in the alcoholic popula- 
tion, providing careful screening is carried out and there is some 
evidence of abstinence in advance from alcohol. 



117 

Mrs. Schneider. Do liver transplant patients require life-long 
monitoring or constant treatment? 

Dr. Starzl. Yes, but it is a very simple situation. I am glad 
Danny Butler is here, because we see him about once a year, and I 
suppose he sees his doctor here about once every couple of months. 
He really just lives a normal life. The people that get out months 
or so after transplantation can do well, just like Norm's famous pa- 
tient who got on a bicycle and rode it from coast to coast. They are 
not strange. You wouldn't even be able to recognize them if you 
met them on the street. 

Mrs. Schneider. You had mentioned in your testimony, Dr. 
Starzl, that at times it is easier to operate, and one finds operating 
better in both Europe and the Far East. I wonder if you could 
elaborate on that. 

Dr. Starzl. There are a number of centers in those parts of the 
world. Some of them will make depositions at the Consensus Con- 
ference — Rudy Krom in Holland, a group working in Munich, and 
a group working in France. They all are representatives that at 
one time trained with us. Then we have trained people in 
Japan 

Mrs. Schneider. But you mentioned that it was sometimes easier 
to operate in foreign countries. I was wondering if you were imply- 
ing 

Dr. Starzl. No, I just meant that they have had an easier time 
setting up programs. For example, Italy just made a decision that 
they were going to set up three transplant programs, one in Milan 
which is on its way, one in Rome, and the third one in an unspeci- 
fied city about which they are presently struggling. But it is known 
there that there are going to be some centers, and they have been 
set up. They are not research centers, they are service centers. I 
think that is going on in Italy, in France, in Germany, in England, 
and so on. England, I think, has now got a second one. 

I think we are behind in our regionalization, if you will, in 
making it feasible to go forward. That is the trouble that Jim Wil- 
liams has gone through. What he has done has been perfectly ex- 
traordinary. 

Mrs. Schneider. In the Modern Medicine magazine in April a 
few years ago, you were interviewed and you had said that now 
you have solved the problems of supply and duct integrity; you are 
now looking for better immunosuppressive techniques to improve 
the survival rates of transplant patients. This interview was con- 
ducted back in 1976, and I wonder what the timing was for the in- 
troduction of cyclosporine? 

Dr. Starzl. Cyclosporine surfaced with a paper given by Jean 
Borel, the Sandoz immunologist, in 1976, and was seized upon by a 
man named Dave White working at Cambridge. An experimental 
supply became available in 1977 in Europe. Many people around 
the States knew about it. We did. But you really couldn't get it. It 
was priceless at first. 

Mrs. Schneider. Now I understand that the process to manufac- 
ture it is a rather cumbersome ordeal. I wonder if you could elabo- 
rate on how expensive it might be? 

Dr. Starzl. I am told by the people in the company it will cost 
for a patient for a year $5,000 or $6,000, something in that range. 



118 

Mrs. Schneider. For a year. 

Dr. Starzl. I am not sure that they would really want me to say 
anything, and I have nothing to do with the company. This was a 
question, though, that was asked at the FDA meeting here 2 or 3 
weeks ago, and that was the answer that was given in a public 
forum. 

But, as Norm said, it has been synthesized. A man named 
Wenger synthesized it. It is thought that analogs will be forthcom- 
ing. The problem with the synthesis presently is about the same as 
with penicillin many years ago, in that the synthetic process is 
cumbersome and takes about 35 steps. I am told that to be commer- 
cially feasible, it has to be in five steps or less. 

So, at the present time, it is a biologic preparation. It is an ex- 
tract from some fungi. You have to grow those fungi and then col- 
lect the extract, and so forth. I think it is cumbersome, but it 
almost certain to become simpler as time goes by. 

Mrs. Schneider. Fine. 

I would like to personally thank you, Dr. Starzl, for your efforts 
last night and this morning. The operation that he was involved in 
was on one of my constituents, and I am very appreciative for your 
personal involvement and oversight in this case. I am hopeful that 
very soon she will be in good shape. 

I thank all of you for your very informative imput. 

Mr. Gore. Congressman Durbin. 

Mr. Durbin. Thank you very much, Mr. Chairman. 

I, several years ago, worked with the Illinois State Senate Judici- 
ary Committee, and we put together the Uniform Anatomical Gift 
Act in the State of Illinois, and tried to set up a procedure through 
our driver's license, I think, very similar to what you described 
today, to increase public awareness. I don't know how successful it 
has been in our State. 

After hearing your testimony, I am wondering if all of our efforts 
in that regard, aside from increasing public consciousness, made it 
any easier for you as a surgeon looking for a donor to have people 
available when you need them. Has it worked? Is it still too cum- 
bersome? 

Dr. G. Melville Williams. Yes, it is far too cumbersome. 

What, I think, would help would be to have many of the so-called 
safeguards removed. For example, why is it necessary for an indi- 
vidual to have two witnesses in order to make a statement "yes" or 
"no" if he wants to donate his body for transplantation? 

Mr. Durbin. I can tell you why, but it still doesn't make any 
sense. 

Dr. G. Melville Williams. Yes, I know. You see, we make it 
very, very hard to opt into the system. There is plenty of evidence 
to state that, given a choice, 2 percent of the people go to the time 
and trouble of filling out the forms, getting their witness — which 
might be strangers in the line waiting to apply for their driver's 
license — I did that once, and everybody thought I was a nut. 

Dr. Starzl. It can be done simply. I worked in Colorado for a 
number of years, about 19 years, and it was no accident that that 
driver's license law that was described earlier was in Colorado. But 
that didn't require witnesses. You expressed an opinion as you 
went through. Now, that probably did not carry the legal weight 



119 

that the Maryland document does. The Maryland document pre- 
sumably would allow the doctor to go right forward without any 
family permission, and I never construed the Colorado document 
that way. 

But what it did do was to create an ambience within the family 
so that everybody knew that this guy checked that off — almost 
always yes — and at the last count when I left there, there were 
about a million of the driver's licenses in Colorado that had been 
checked off— yes. 

Mr. Durbin. Does that work, though, States like Colorado? 

Dr. Starzl. I don't think it works in terms of a point-to-point 
procurement. But I must say that there were a lot of donors in 
Colorado. It was a very, very effective donor center, one that was so 
effective that, for a long time, it was one of the main sources of 
kidneys for New York City and also for the west coast. It was a 
very effective center. 

But that all is kind of nonspecific. I will bet you anything that 
they are busier than heck out in San Francisco because, whenever 
extra-renal organs get into the picture, they attract a lot of atten- 
tion. It automatically gears up the kidney procurement. It really 
helps. So these are reinforcing procurement problems, the renal 
and the extra-renal ones. 

Mr. Durbin. Many Members of Congress write weekly columns 
and send them back home about things we do in Washington. I 
would like to write a column about this testimony today. I would 
like to end it by making specific recommendations to the people 
that read it. I am trying to, from your testimony, come down to 
some very basic things that everybody could do, having heard what 
is needed and really appreciating what they can do. 

I think that the first thing — and Chairman Gore deserves com- 
mendation from all of us, because there are plenty of things that 
we could be talking about and I can't think of anything more im- 
portant today, and he in his effort has increase public awareness — 
but as he mentioned earlier, just sitting down with member of your 
family, and at least have an understanding about what your per- 
sonal feelings are so that, if there is an accident where your life is 
threatened or a fatal accident, they will have an idea what decision 
to make. That sounds like a pretty valid first step. 

I guess the second one is — I looked at may own driver's license 
and, having worked on that law, I never signed the back of it on 
the donation of organs because I was never asked in line and it 
never crossed my mind. It seems to me that we ought to be more 
conscious when we renew our driver's licenses about these provi- 
sions in some States, and perhaps contact legislators in some States 
that don't have this law. 

Would the third thing be to contact local medical societies and 
ask them what kind of organ donor societies are available or associ- 
ations? I have been contacted at church picnics about donating my 
organs. 

Dr. Starzl. I think that is an important thing to do. It is curious 
that I never really took the necessary effort to do it voluntarily. I 
was asked to do it by the Journal of Pediatrics. This was involving 
an interest in which I had a major investment, that is the liver 



120 

transplantation, because the small donors, as you have heard this 
morning, are the ones who are in short supply. 

At the same time, in a quite formal surgical literature, many 
papers are now coming out. As you pointed out, Mel left a very im- 
portant meeting in Holland that was considering some of these 
questions. Studies were being reported at the meeting about the 
function of different organs when taken out in conjunction with 
other organs. That is in the literature, and it is apt to increase the 
physician awareness. 

Just so you know exactly what I am talking about, we heard 
from Mel that the national incidence of failure of kidneys to func- 
tion promptly is rather high, 30 to 35 percent, in that range. But in 
the heart donors, at least in the Eastern half of the United States, 
that figure is less than 10 percent for malfunctioning kidneys, and 
in liver-plus-heart-plus-kidney donors, it is the lowest of all, prob- 
ably in the order of 5 to 10 percent. 

What this really means is that the removal of these extra organs 
does not jeopardize the kidneys at all. As that kind of information 
gets out, I think it will automatically impact on the physician ac- 
ceptance and acceptance by the kidney transplant surgeons. 

Mr. Durbin. What can the average person do to help along in 
this physician awareness? Is it a waste of time to write a letter to 
your local medical society and say that I hope you are participating 
in some sort of education program? 

Dr. Starzl. I think that is going to have to come from us. We 
have been negligent. Mel, by virtue of being president of the 
American Transplant Society— which has an educational arm — 
should be able to do something. I think that we are going to have 
to work on that, because we are asking you to do things we are not 
even doing our own homework on, it looks like. 

Dr. G. Melville Williams. Doesn't the Emergency Medical Serv- 
ice — isn't that a federally sponsored program? 
Mr. Gore. They get some assistance, yes. 

Dr. G. Melville Williams. I remember several years ago trying 
to drum up interest, stating that within that system there be devel- 
oped some guidelines for the recognition of donors. As it stands 
now, I don't believe that that is done. In other words, this is some- 
thing that is within the boundaries of Federal enterprise. 

Mr. Gore. We are going to hear a specific recommendation on 
that from a witness tomorrow, and we anticipate including that in 
our lengthy list of recommendations when we report at the end of 
the 3 days of hearings. I think that is an excellent suggestion. 

Mr. Durbin. Dr. Shumway, could I ask you a question or two 
here? I am particularly interested in some aspects of your testimo- 
ny. 

Is there a rather free exchange now of information among coun- 
tries that are interested in transplantation? 

Dr. Shumway. Yes; there is. I know more, of course, about hearts 
and lungs, and so forth, than the others, but most of the people 
who are interested in developing these clinics doing transplant of 
the extra-renal organs such as heart or heart-lungs are people who 
have been through our place and who spent time with us. And 
there is a free exchange of information. 



121 

Mr. Durbin. Do you feel there is any resistance within the medi- 
cal profession to the idea of transplantation? I got the impression 
about 10 years ago in speaking to a heart surgeon that the idea of 
transplantation was something that was considered too experimen- 
tal, at least in the heart area. Has that changed remarkably? 

Dr. Shumway. I think it is changing. I think the good results 
that are currently possible have pretty much dispelled all of that 
original doubt, but there are still units, though, that, for one 
reason or another that are very difficult to understand, are having 
trouble with the survival statistics — after transplantation of the 
heart, for example. But this is less and less of a problem. Today, 
there must be a half a dozen centers in Europe that have good pro- 
grams in heart transplantation, and probably 12 to 15 such centers 
in the United States. 

Mr. Durbin. Can we look to the day in the next 5 or 10 years 
when heart-lung transplants will be considered at least as common 
as kidney transplants? 

Dr. Shumway. I don't think so, no. I don't believe there will ever 
be the incidence of transplantation of those organs that you see in 
the kidneys, nor do I think there will be the need. It is possible, but 
certainly not in the next decade. 

Mr. Durbin. I am interested in that comment that there 
wouldn't be the need. Could you expand on that a minute? 

Dr. Shumway. Yes; for example, in cardiac work, the original 
conditions that mandated the possibility of transplantation are now 
being ameliorated by new operations that are being developed, dif- 
ferent techniques, even occasionally we might get around to pre- 
ventive medicine from the standpoint of coronary artery disease. 
On the horizon, there is the use of the laser to melt away coronary 
lesions. So, there are all kinds of developments that are, I think, 
going ahead in that field that would tend to keep the incidence 
somewhat lower than the kidney. 

Mr. Durbin. Do you see it as advisable from a national viewpoint 
that there be more centers in the near future that would consider 
heart-lung transplantation as at least a procedure that they would 
have people proficient to perform? 

Dr. Shumway. Yes; I think so. As Dr. Starzl said, people are 
being trained in these aspects of transplant and are now moving to 
other medical centers around the country. So, there will certainly 
be an increasing number of such cases performed. 

Mr. Durbin. Does this particular procedure, the heart-lung trans- 
plantation, call for a substantial investment in new equipment for 
a hospital that would want to undertake the program? 

Dr. Shumway. No; not at all. 

As a matter of fact, as I tried to intimate in some of my earlier 
remarks, the early results from heart-lung transplant patients 
seem to us to be better than the results from heart transplantation 
alone. There are many possible reasons for this, and some of them 
are entirely speculative. But, nonetheless, it is an extremely inter- 
esting era that I think will be explored much more fully in the 
next few years. 

Mr. Durbin. I want to commend the panel, too. I think you make 
some very telling points on the economic aspects of this discussion. 
I do not envy your job for 1 minute. I have been to Houston and 



122 

saw what Dr. Cooley faces every day with people waiting in the 
room begging for the chance to be operated upon, and you have to 
face that day in and day out. That human aspect is something that 
I think is a burden that many of us don't appreciate until we have 
been there. 

But I would say that, from a governmental viewpoint, we are 
coming down more and more to a question of it is your money or 
your life. When it comes to health care and the expenditures of 
money in light of some of our fiscal problems, I think that the 
American people are saying quite clearly that they want good 
health, they want the best medical techniques available, and I be- 
lieve they are prepared to pay for it. 

When we hear what you have said concerning the long-term sav- 
ings, Dr. Starzl, the long-term savings of this type of approach, it 
makes our job that much easier to concur with that belief that we 
have got to have the best health care in this country available to 
everyone. 

Thank you all. 

Dr. Shumway. One thing that should be pointed out is that, in 
the world activity in health care, the United States is absolutely 
preeminent. It may be falling behind in automobiles and various 
other technologies, but in health we are way ahead. I think we 
would certainly like to keep it that way. 

Mr. Durbin. You bet. Thank you very much. 

Mr. Gore. We certainly would. 

Just following up briefly on my colleague's questions, 15 years 
ago, an NIH task force estimated, Dr. Shumway, 12,000 to 32,000 
heart transplants a year. 

Dr. Shumway. That was absolutely ridiculous. I don't know how 
they sat down and arrived at that figure, but it is quite preposter- 
ous. That would be a situation perhaps when we would get around 
to the point when we could use animal donors for transplantation 
purposes. Those figures are phony. 

Mr. Gore. You mentioned the subject of animal donors, the so- 
called xenografts. You were quoted recently as saying that you be- 
lieve that ought to be actively studied? 

Dr. Shumway. It is, yes. 

I think one point — and Dr. Starzl knows more about this because 
of the renal xenografts that were used in Colorado in the early 
days — but in New Orleans, for example, one chimpanzee kidney 
survived for 10 months in a human recipient. What we are talking 
about today in terms of homografting or allografting may be, in the 
long view of the subject, just a step toward the availability of other 
kinds of donors, namely xenografts. But there is quite a bit of work 
going on in this area now. 

Mr. Gore. In other words, partly because of the shortage of 
human donors, you are actively exploring the possibility of trans- 
planting animal hearts into patients. 

Dr. Shumway. Yes, but it is still in the distant future. I wouldn't 
want anybody to think that this is just around the corner. This is 
really a developing area of research, even now. 

Mr. Gore. I see. 

Dr. Starzl. Also, there has been some understanding about the 
nature of the animal donors that is a little bit disquieting since 



123 

those early days. I have had experience with baboon and chimpan- 
zee heterografts, what you are calling xenografts. The baboon, I 
think, is too far away from the human, although those kidneys did 
function for about 2 months or maybe even a little longer than 
that. But the rejection was very hard. 

I think what Norm may be driving at is that there has been a lot 
of awfully good information coming out about the effect of cyclo- 
sporin in heterografts. It, of course, has improved the outlook 
there as well. 

But I was reminded that we, in a very serious emergency situa- 
tion at one time, did a chimpanzee heterograft to a child whose 
first human liver had failed, so we were really against the wall. We 
got from the Air Force a chimpanzee that was 3 or 4 years old, and 
the chimpanzee was brought to Denver in a cage and was brought 
over to my house and had tea. It actually was able to have tea. 
When it finished it made some human gestures, and so forth. It 
was so human, it was uncanny. I was really uneasy about taking 
that little chimpanzee's liver. I would never do it again. It is too 
close to being human. 

I saw a program not long ago on television about the origin of 
man, and it made it pretty clear that the gestures and the facial 
expressions and the powers of reasoning that chimps have are so 
close to human. I would have a lot of trouble doing that again. But, 
to me, that is the only animal right now that is close enough to the 
human to hold a lot of promise of immediate application. It is prob- 
ably a sentimental point of view anyway. 

Mr. Gore. Just briefly, how do artificial organs play into this 
problem? Is it safe for me to assume that the future utility of an 
artificial heart is problematic, and the number of patients who will 
benefit is probably sharply limited; and second, that it is highly un- 
likely that we will see artificial kidneys or livers or pancreases or 
lungs at any time in the foreseeable future? 

Dr. Shumway. I think that is true. I think the recent experience 
in Utah lasted much longer than anybody had anticipated. Certain- 
ly, the kind of apparatus that is available now and was used there 
is in no way similar to what you would expect the final artificial 
heart development to be like. So, I personally, believe we will be 
using xenografted tissue before we have the inexhaustible totally 
implantable nonheat-producing kind of power source. It will prob- 
ably be in our automobiles and refrigerators first, before artificial 
hearts. 

Mr. Gore. Congressman Reid, did you have any questions? 

Mr. Reid. No, I don't, Mr. Chairman. Thank you. 

Mr. Gore. Congresswoman Schneider? 

Mrs. Schneider. I just wanted to follow up on some of the ques- 
tioning a little earlier on cyclosporine. Where does it sit right now 
with the Food and Drug Administration? 

Dr. Starzl. They had a meeting over there on the 25, and they 
asked me to give data for it because we had one of the studies. The 
advisory board voted unanimously to move to whatever the next 
step to general release is, to go forward with that. I don't really 
know what the pathway is from that point onward, but certainly it 
passed through that the first steps quickly. 



124 

Mrs. Schneider. Is there any reason that you presented or others 
presented to the Food and Drug Administration as to why it 
shouldn't be used? 

Dr. Starzl. No; it was uniformly favorable testimony, I would 

say. 

Mrs. Schneider. OK. Thank you very much. 

Mr. Gore. How close are we to offering any sort of hope to the 
1.5 million diabetics who I am told would benefit from a pancreatic 
transplantation procedure, Dr. Williams? 

Dr. G. Melville Williams. I think this will probably be the next 
organ to surface in a dramatic way in transplantation. 

The problem with diabetes is that it is really quite different in 
nature than the other diseases that we are talking about where 
failure is equivalent to death. The pancreas can fail and a patient 
can be sustained on insulin for a long period of time. So, the point 
at which one intercedes is a point way down the line somewhere 
after the complications have already developed. 

So, this has, been one of the problems. Most of the diabetics who 
have been transplanted so far have had concomitant kidney fail- 
ure. 

Mr. Gore. I see. 

Dr. G. Melville Williams. When and if the results become well 
known and if they continue to improve as they are, then it would 
give us justification to intercede at an earlier time period. I think 
it will, in the next 3 or 4 years, be a very important organ to trans- 
plant. 

Mr. Gore. Dr. Starzl? 

Dr. Starzl. Probably the time is here now. We have done two 
pancreas transplants over there in Pittsburgh. We didn't do it for a 
long time because we were not satisfied that the technical aspects 
of that operation had been worked out. But I am satisfied that that 
is the case now. I think that we will go forward at a steady, al- 
though not a panicky rate, with the pancreas. 

There are a number of centers around the country that are all 
doing good work. Minnesota has done more than any other center. 
The University of Cincinnati is a good one. Some of the surveys 
from these regional procurement groups— yours, for example- 
showed quite a surprising number of pancreases being done. 

I think the biggest deterrent to going forward with pancreas 
transplants is the very one that Mel described, and that is that 
there is a very sound alternative form of therapy. But in some pa- 
tients, it doesn't work. Some people die from diabetes mellitus. On 
the way to dying, they usually develop multiple organ failure, in- 
cluding the kidney. So, perhaps it is appropriate— you sounded as if 
you thought maybe that was being too restrictive— but I think it 
may be appropriate to not even consider a pancreas until you have 
bone fide evidence of failure of the second organ system, and that 
would usually be the kidney or the eyes, impending blindness. 

Do you want to comment on that? 

Dr. G. Melville Williams. Yes; that is currently, I think, the ac- 
cepted way. But I suspect that, when the results get better, the 
demand will be made to transplant somebody with a creatinine of 
2.2, as opposed to transplanting him when he is on dialysis. 



125 

Dr. Starzl. Then, there is really going to be a horrible crunch, 
but I don't even want to think about that. I think that, in many 
ways, the transplantation of the pancreas and the liver are, al- 
though they are said to be compatible, basically incompatible pro- 
cedures using the same donor. 

Mr. Gore. We are talking then in descending order of how 
common they are, the kidney transplants, liver transplants, heart 
transplants, heart-lung transplants and pancreas transplants. The 
only other item on the agenda would be corneas; is that right? 

Dr. Starzl. No; the intestine is coming up also. 

Mr. Gore. The intestine is coming up also. 

Dr. Starzl. Yes, sir, it had never been possible, although many 
people tried over two decades, to obtain chronic survival in dogs 
after intestinal transplantation. Suddenly, it became possible. A 
group up in London Ontario did it and we did it. We have two dogs 
that are 600 or 700 days after complete midgut, complete intesti- 
nal, transplantation. They look completely normal. So, I think that 
is another area that will be explored. 

Here, I think that, at least until it really gets worked out, I 
would call that an experimental procedure. 

Mr. Gore. I see. And then, of course, bone marrow transplants 
are in a slightly different category because it is renewable? 

Dr. Starzl. Yes; that is no longer experimental. That is a spec- 
tacular story of its own. 

Mr. Gore. Yes. 

How are the two pancreas transplants doing? 

Dr. Starzl. They are doing fine. They are former diabetics. 

Mr. Gore. Let me thank you again for coming and for honoring 
us with your presence. You gentlemen are heroes in America for 
the lives you save, for the work you do, and we can't thank you 
enough for taking time out of your very important activities to 
share with us in an effort to try to develop a national strategy for 
what is surely going to be a dramatic upsurge in the need to obtain 
organs and to deal with the surrounding problems in a more 
rational and effective way. Thank you very much. 

Dr. Starzl. Thank you. 

Mr. Gore. Our final panel today is made up of Mr. Donald W. 
Denny, director of organ procurement, Transplantation Office in 
the University of Pittsburgh School of Medicine in Pittsburgh; Ray- 
mond Coleman, founding president of Donor Alert, Warwick, R.I.; 
and William W. Pfaff, M.D., past president of South-East Organ 
Procurement Foundation at the University of Florida College of 
Medicine in Gainesville, Fla. 

We will begin with you, Donald W. Denny, director of organ pro- 
curement, Transplantation Office, University of Pittsburgh School 
of Medicine. Welcome. 

Without objection, your entire text will be included in the record, 
and we invite you to proceed with your presentation. 



23-029 0-83 



126 

STATEMENTS OF DONALD W. DENNY, DIRECTOR OF ORGAN PRO- 
CUREMENT, TRANSPLANTATION OFFICE, UNIVERSITY OF 
PITTSBURGH SCHOOL OF MEDICINE, PITTSBURGH, PA.; WIL- 
LIAM W. PFAFF, M.D., PAST PRESIDENT, SOUTH-EAST ORGAN 
PROCUREMENT FOUNDATION, UNIVERSITY OF FLORIDA COL- 
LEGE OF MEDICINE, DEPARTMENT OF SURGERY, GAINES- 
VILLE, FLA.; AND RAYMOND COLEMAN, FOUNDING PRESIDENT, 
DONOR ALERT, WARWICK, R.I. 

Mr. Denny. Mr. Chairman, members of the subcommittee, I 
thank you for conducting these hearings today. The subject of 
organ procurement and distribution for transplantation is of na- 
tional concern. 

Despite the headlines that you perhaps have seen, and despite 
some of the comments that I have heard here today, I would like to 
indicate at the outset that I believe there is in effect today in this 
country an effective system for the procurement of vital organs for 
transplantation. It is not a random process. 

The process is not an easy one. The system is not a perfect one. 
We have heard that there are this year approximately 2,500 post- 
mortem organ donors, but yet all studies indicate that this is any- 
where from one-tenth to one-third of the potential donors from 
whom organs could be recovered. 

The recovery of organs for transplantation is a three-tier process. 
In trying to understand where the problems lie behind the short- 
age of organs, behind the fact that we are now recovering so few of 
the organs from all of the potential donors, I would like very brief- 
ly to outline this three-tier process. The three tiers are, in short, 
the organ procurement programs in this Nation; the physicians 
and nurses at the acute care hospitals in the United States; and 
third, all of us, the general public, those of us who inevitably will 
die, those of us who will succumb at one time or another, and who 
couid be potential vital organ donors. 

The first tier, the organ procurement programs in this country: 
There is a nationwide regionalized system for the recovery of 
organs for transplantation. There are in the United States approxi- 
mately 110 organ procurement programs. These 110 programs have 
been established over the past several years primarily to serve the 
need for the recovery of kidneys for transplantation. In recent 
years with the development of extra-renal — that is, organs other 
than kidneys — transplantation, these 110 organ procurement pro- 
grams have been challenged to recover hearts, livers, heart-lungs, 
pancreas, and so forth, as well as kidneys from their donors. 

The 110 organ procurement programs in this country today are, 
in large part, run by and made effective by the organ procurement 
professionals, nonphysicians like myself, most of whom belong to a 
nationwide association of coordinators, the North American Trans- 
plant Coordinators Organization. Over 360 of us in this country 
labor to provide organ donation education of physicians and nurses, 
as well as the public. We are also available generally to receive the 
referrals of donors, to evaluate donors, and to assist on the scene in 
donor hospitals in making possible the necessary clinical, medicole- 
gal, and psychological adjustments which are necessary to recover 
the organs for transplantation. 



127 

The 110 organ procurement programs and their associated organ 
procurement coordinators struggle to provide professional educa- 
tion, to doctors and nurses especially. In my area, I speak over 120 
times a year to medical staffs in acute care hospitals, to critical 
care nurses in intensive care units and emergency rooms, trying to 
help them understand the importance of recovering organs for 
transplantation, conveying to them who donors are, helping them 
understand how to manage these donors so that vital organ func- 
tion can be sustained, helping them understand the psychology of 
the donation process in dealing with grieving families. 

But it is not just a matter of information giving, unfortunately. 
We are all besieged by sources of information. We are all besieged 
by demands to pay attention to urgent needs. Maybe this is espe- 
cially true of physicians and nurses. 

Information giving is frequently not enough— helping a doctor 
understand that there is a need for organs, who donors may be and 
what the process is. Sometimes the challenge is to excite them, to 
make them feel it as we feel it. And sometimes we despair because 
we are unable, through information giving or through challenging 
their feelings of caring for dying patients, we are unable to secure 
their cooperation. 

The dissemination of information to physicians and nurses car- 
ried out by the 110 organ procurement programs in this country 
has been spotty in some areas. We have received referrals of 
donors and calls from physicians as far away as the west coast who 
have called Pittsburgh to ask who donors are, what should they do 
because they think they have a donor in the hospital, and they are 
unaware of their own local organ procurement programs. I don't 
mean to fault the organ procurement programs in these other 
areas of the country. It is a tremendous job to try to educate and 
sustain interest among physicians and nurses in organ donation 
when their primary concern is caring for living patients, patients 
who are ill of other diseases. 

Because of the apparent lack of a uniform method to educate 
physicians and nurses in this country today, because of the appar- 
ent holes in our educational system, the North American Trans- 
plant Coordinators Organization recently established a 24-hour in- 
formation and referral service for doctors and nurses throughout 
the country. An 800 number, so it is a toll-free call, is available to 
physicians and nurses anywhere in the Nation who are not aware 
of who donors may be or who do not know how to contact their 
own local procurement program. This 800 number is a mnemonic 
number that is easy to remember, 800-24-DONOR. You pick up 
the phone and dial 800-24-DONOR. 

Mr. Gore. How recently was this established? 

Mr. Denny. This was established 10 days ago. 

Our struggle now is to acquaint physicians and nurses through- 
out the country with the availability of this number. Let me stress 
that this 800 number is not meant to supplant the 24-hour referral 
nu . m ^ rs in P lace at the 110 organ procurement programs. Instead, 
this 800 number is meant to supplement it, to provide information 
for a doctor who does not who to call in his own area and, believe 
me, there are many of them. 



128 

The organ procurement programs, going further into my brief 
look at this three-tier process, also, in addition to providing educa- 
tion, provide the manpower and the technology for the recovery of 
organs for transplantation. Surgeons, physicians, and paraprofes- 
sionals like myself are available 24 hours a day, around the clock, 
throughout this country, to recover vital organs for transplanta- 
tion. We don't lack the skill, we don't lack the manpower, we don't 
lack the technology to recover organs for transplant. Every organ 
procurement program has as one of its major goals the recovery of 
kidney ior transplantation for the nearly 6,000 people who are 
now waiting for renal transplantation in this country. 

Additionally, however, the organ procurement programs collabo- 
rate to a great degree in the recovery of extra-renal, nonkidney, 
organs for transplantation. Cooperation between these 110 organ 
procurement programs has developed dramatically over the past 2 
years. Witness the fact that the University of Pittsburgh, which 
has a very large waiting list for liver and heart transplant pa- 
tients, now works collaboratively with other organ procurement 
programs around the country in recovering two-thirds of the livers 
that we transplant and three-fourths of the hearts that we trans- 
plant. In other words, our own area, within 140 miles of Pitts- 
burgh, which is the geographic region that our organ procurement 
programs covers directly, isn't sufficient to provide the organs for 
transplantation that we need, especially in the area of livers and 
hearts. 

Through the collaboration of other organ procurement programs, 
we have flown as far west as Oklahoma City and Fargo, N. Dak., 
and as far south as Houston and Miami to recover organs for trans- 
plantation through the good efforts of organ procurement profes- 
sionals in those area. 

Yet, I have to admit before this committee this morning that, al- 
though we have collaborated with almost 50 of the 110 organ pro- 
curement programs in this Nation recovering extra-renal organs, 
there are still many of these programs that do not call us when 
they have kidney donors, and do not give us an opportunity to re- 
cover livers or hearts from their donors. 

The system is developing. One of the reasons that we don't re- 
ceive collaboration from all of the organ procurement programs is 
that they are in need also of education. They need also to under- 
stand that working with us in recovering hearts and livers is not 
going to compromise their kidneys which they need desperately for 
transplantation locally. 

In addition to organ procurement education, and procurement 
services, organ procurement programs are actively involved in the 
distribution of organs for transplantation. In the case of kidneys— 
you shall hear from Dr. Pfaff in a few minutes— there is a comput- 
er system which is an excellent means of locating suitable recipi- 
ents nationwide for transplantation of kidneys. When we have kid- 
neys available in the Pittsburgh area that we are unable to trans- 
plant among our patients, the computer will print out for us a list 
of suitably matched recipients throughout the country. 

The computer system has limtitations, however. In the distribu- 
tion of extra-renal organs, a somewhat different system has been 
utilized to supplement it. The computer is a fixed-base operation. A 



129 

terminal is located in my office, but there is no terminal in the 
community hospital where I may have a donor. What do I do at 2 
o'clock in the morning when a donor is identified in a community 
hospital 100 miles from Pittsburgh and I am preparing to sit down 
and talk with the grieving family to suggest that they donate 
organs? I need to know immediately where a suitable recipient for 
the heart or liver may be. In the case of kidneys, we can wait until 
the organs have been removed and access the terminal when we 
get back after the donor surgery. In the case of hearts and livers, 
we need to know where the recipients are before we remove the 
organs because of the very limited preservation times that we have 
for these organs. 

I can't access a terminal at 2 o'clock in the morning from 100 
miles away from my office. Instead, what we have now is a 24-hour 
telephone system, also established by the North American Trans- 
plant Coordinators Organization, a telephone system which is con- 
trived to provide information concerning the needs for hearts, 
livers, heart-lungs, and other extra-renal organs to organ procure- 
ment professionals around the country. Twenty-four hours a day, if 
we access a central telephone number, we are informed through a 
recorded message of what organs are needed from Stanford, Calif., 
to Pittsburgh, from New York City to Virginia to Memphis, Tenn. 

Fifteen extra-renal transplant centers now cooperate and list 
their extra-renal organ donor needs on this 24- Alert System. The 
calling coordinator or physician will be told the blood type, the size 
of the donor that is sought, the distance that the transplant center 
is willing to fly, the telephone number to call if a donor is availa- 
ble. The caller is also informed of the potential recipient's medical 
condition, that is, the degree of urgency for transplantation. 

Brandon Hall today is flying back to Memphis for his liver trans- 
plant. This liver transplant was made possible by the fact that the 
organ procurement coordinator in Virginia who recognized the 
donor called the 24-Alert telephone number and was informed 
through this service that the University of Tennessee, had an 
urgent need for a pediatric donor liver of a given size and blood 
type for Brandon Hall. He copied down the phone number and 
gave them a call. 

This system doesn't sound very sophisticated. Computers sound 
so much more high-tech, don't they, than phones and recorded an- 
swering services? But this system works. It is effective. It is availa- 
ble to all of us, and it has made possible in the last 6 months the 
transplantation of 48 livers at 5 centers, and 25 hearts at 9 centers. 

Going on briefly in my description of the three-tier system, the 
second tier are the health professionals, the doctors and the nurses 
in this country, who are in a position to recognize suitable donors 
to provide the organs for transplantation. 

I have been an organ procurement professional for the past 9 
years. I am glad to say that the physicians and nurses in this coun- 
try, by and large, support organ donation. Unfortunately, however, 
verbal support isn't sufficient. We also have to have their active 
support. Unfortunately also, it is accurate to say that many physi- 
cians and nurses do not collaborate with us in recovering organs 
for transplantation. 



130 

Ignorance, apathy, indifference, they all play a part. But perhaps 
the biggest problem is the medicolegal problem— physicians and 
nurses who fear that if they cooperate in the recovery of organs for 
transplantation, they will be vulnerable to litigation. We live in a 
litigious society, and physicians especially know how damaging nui- 
sance lawsuits can be. As a result, they oftentimes practice defen- 
sively. Their patients are not waiting for transplants, and our re- 
quests that they help us sometimes fall on deaf ears because of 
their fear of medicolegal vulnerability. 

Brain death is a central issue related to organ donation. You 
can't escape it. By definition, all donors are victims of brain death. 
They are medically and legally dead because their brains are dead. 
They are no longer thinking, feeling, willing, reflexive people. Arti- 
ficially their hearts and their respiratory systems continue to func- 
tion, and this is what allows the viability of the organs to be pre- 
served until they are removed and chilled. 

Physicians are especially concerned about the public's acceptance 
of brain death. Thirty-five States now have passed statutes recog- 
nizing that brain death is death. Fifteen States do not have laws 
defining brain death, but in those 15 States, common law or apel- 
late court decisions allow the recovery of organs for transplanta- 
tion following pronouncement of death on the basis of brain death. 

But despite legal support, doctors and nurses often fear that the 
public does not accept brain death and do not cooperate with us. 
Less than 1 percent of all the deaths that occur in this country 
occur under the circumstances of brain death and among the popu- 
lation that is within the right age frame to be a donor. 

In my mind, the health professionals, the doctors, and the nurses 
in this country, are the weak link between the first tier, the organ 
procurement programs, and the third tier, the lay public. In my ex- 
perience in the Pittsburgh area and in Pennsylvania generally, ap- 
proximately one out of five families says no to organ donation; but 
four out of five families who are approached and offered the oppor- 
tunity, say yes. These figures are not duplicated in many other 
areas of the country, however. As you have heard today, cultural, 
racial, and educational factors influence whether or not members 
of the public will say yes to organ donation at the time of death. 

The American public, however, does have a big heart. One of the 
gratifying aspects of my job is that I deal with these grieving fami- 
lies and see firsthand the value that it provides the grieving family 
to be told that the organs from their loved one now sustain life in 
two, three, four, or five other patients. 

In my experience, only 1 out of 10 families of a brain dead victim 
initiates the request to donate. Most families at the time of death 
are too overcome with their own grief to remember the need for 
organs. I am not concerned by the fact that the national Kidney 
Foundation poll recently found that only 40 percent of the white 
population and 20 percent of the black population would be willing 
to donate organs of their loved ones at the time of death. We don't 
want to believe that we are going to die. We don't want to believe 
that our loved ones are going to die. As a result, when we are 
asked— not at the time of death, but at the time of life— whether or 
not we would donate, of course, we say no. It is too scary to even 
consider that these people might die. At the time of death, as I 



131 

said, only 1 out of 10 families initiates the request to donate. But 8 
of those 10 families, in my experience, do donate if they are offered 
the opportunity. 

The problem comes, again, at the medical professional level, the 
need for physicians and nurses to adequately explain brain death 
to the families and to offer donation. It is so difficult sometimes for 
doctors and nurses who, themselves, grieve when they lose a pa- 
tient to sit down and try to explain to a family that their loved one 
in the intensive care unit is dead. It is especially difficult because 
this patient does not look dead. He is, remember, a victim of brain 
death. Artificially, his heart and his lungs are continuing to func- 
tion. 

To try to explain to a family that this brain-dead victim who 
looks as though he is alive and merely comatose is really dead is a 
difficult for a physicians, and sometimes they shirk it. Sometimes 
they shirk it because of their own grief, their own pain, the assault 
on their integrity which they are experiencing because of the 
death. Sometimes it is so much easier for a physician to distance 
himself from the family. 

The American public is hungry for information about organ do- 
nation. Thousands and thousands of donor cards are distributed by 
our program and other programs around the country, but it is not 
enough. We need more public education, not only with regard to 
organ donation, but with regard to brain death as well. It is time 
that we stopped hiding brain death and talked about it openly. It is 
time the medical profession talked about it openly. 

Public education in the past has been primarily aimed at the 
people who already are convinced that organ donation is a good 
thing. Public education is largely directed toward white middle- 
class America. We need public educational efforts which are direct- 
ed toward population subgroups, Spanish Americans, black Ameri- 
cans, Americans from the Mediterranean Basin, and so on. These 
groups do not donate with the same high frequency as the white 
middle-class public does. 

Physicians and nurses are consumers of the media, and they gen- 
erally follow and do not lead public opinion. If we educate the 
public, we will also indeed be educating the medical professionals. 
If they feel that the public is comfortable with brain death and 
with organ donation, they will be much more likely to collaborate 
with us. 

I have five recommendations. First of all, it is time that the 
transplant professionals in this country recognize that they can't 
do the job alone. There is a need for a national task force to be 
composed of leaders from government, medicine, organ procure- 
ment, and interested lay groups to tackle the problems impeding 
the recovery of organs for transplantation. It is time that the trans- 
plant professionals in this country recognize that they need to in- 
volve their colleagues in the medical profession. The neurosur- 
geons, the neurologists, the critical care medicine physicians, the 
emergency physicians, the pediatricians should be members of such 
a task force. They are the physicians who will recognize donors. 
They are the people who need to be convinced that it is important 
to work with us. 



132 

The critical care nurses are by far our most vital ally. They, too, 
should be involved in a national task force. This task force should 
be given the charge of coming up with solutions for developing and 
improving the system nationwide. 

My second recommendation derives from the fact that every hos- 
pital in this country must be certified to function, must be certified 
on several levels. Departments of health in the various States have 
the responsibility of certifying hospitals in their States. The Joint 
Commission for the Accreditation of Hospitals also provides ac- 
creditation of hospitals on a national level. 

There should be developed for accreditation two requirements 
either on the State or on the national level. The first requirement 
should be that there be a policy and an operational protocol for the 
determination of brain death. Second, there should be a require- 
ment for certification that every hospital establish a policy and a 
protocol for recognizing potential donors and referring donors for 
the nearest organ procurement program. 

Doctors refer donors. Hospitals don't refer donors, but if the hos- 
pitals have the rules and the regulations, the doctors may be made 
more willing to comply, to cooperate. 

My third recommendation: there should be a financial incentive 
program established by the Health Care Finance Administration, 
which has the responsibility of funding kidney transplantation. A 
financial incentive would reward hospitals at which donors are 
identified and from whom organs are recovered. 

It is well known that kidney transplantation is much more cost 
effective than is hemodialysis or peritoneal dialysis for the treat- 
ment of end-stage renal failure patients. 

This country, and you and I as taxpayers, have an incentive in 
seeing more people transplanted, if only because it costs less. It 
makes good sense to me to recommend that the Health Care Fi- 
nance Administration provide a financial incentive to those hospi- 
tals from which kidneys are recovered. 

Since almost every postmortem kidney donor is also a potential 
postmortem extra-renal donor, this will increase the number of 
extra-renal organs available. 

My fourth recommendation is that there is a need for strength- 
ening public and professional education. Public education has been 
tried in many forms on the local level, for example, health fairs, 
talks to school groups. These kinds of local educational efforts, to 
my mind, are not effective. 

What is effective is use of the national media, not only to provide 
information about donation and brain death, but to excite people. 
We have to inform, but we have to motivate, as well. We have to 
touch their feelings. 

There is much more work that we could do in public education. I 
would like to see the American Advertising Council take on a cam- 
paign in this country to help educate Americans about organ dona- 
tion. 

Finally, there is a need for statistical information. As we have 
heard today, we have to talk in general figures, because nobody 
really knows how many potential donors there are in this country, 
for instance. 



133 

Nobody really knows how many potential donors are referred. 
Nobody really knows how many end-stage renal disease patients 
there are in this country. 

Nobody really knows how many potential recipients of extra- 
renal organs there are. One vital question, I think, needs to be ad- 
dressed, and that is how many potential pediatric donors are there 
between the ages of 6 months and 5 years? 

The need for pediatric liver donors between six months and five 
is tremendous. We have a waiting list of over 35 children in this 
age bracket who are waiting for liver transplants. 

I know, we all know that many of them will die because we will 
not find organs for them. We may be faced with the fact that there 
are not enough potential pediatric donors in the Nation to meet 
the needs of all of these youngsters. 

Again, let me congratulate this subcommittee, Chairman Gore, 
members of the subcommittee, for your interest, for your efforts in 
spotlighting the accomplishments and the problems and the goals 
that we strive for as the future unfolds for us in what is a very 
promising time for transplantation. Thank you. 

[The prepared statement of Mr. Donald W. Denny follows:] 



134 

TESTIMONY ON 
ORGAN PROCUREMENT AND DISTRIBUTION 
FOR TRANSPLANTATION 
BEFORE THE 
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT 
COMMITTEE ON SCIENCE AND TECHNOLOGY 
U.S. HOUSE OF REPRESENTATIVES 
APRIL 13, 1983 



DONALD W. DENNY 
DIRECTOR OF ORGAN PROCUREMENT 
TRANSPLANT FOUNDATION 
UNIVERSITY OF PITTSBURGH 



135 



Testimony of DONALD W. DENNY p.1 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science" and Technology • 
U.S. House of Representatives 
April 13, 1983 



My name is Donald W. Denny. I am the Director of Organ 
Procurement for the Transplant Foundation at the University of 
Pittsburgh. I am also a member of the North American Trans- 
plant Coordinators Organization (NATCO), a professional assoc- 
iation of transplant and organ procurement coordinators from 
the United States, Canada and several foreign countries. My 
testimony today will primarily reflect my personal experience, 
attitudes and values. I am also designated as the official 
representative of NATCO at these hearings, but when expressing 
the point of view of this association of over 350 transplant 
professionals, the context of my remarks will identify my 
position as a spokesman. 

I wish to express my appreciation to the Chairman and 
members of this Subcommittee for conducting these hearings into 
the subject of post mortem vital organ procurement and dis- 
tribution for transplantation. I have been closely involved. in 
organ procurement for the past nine years, have participated in 
the organization of and have administered two organ procurement 
programs. I believe that the subject of these hearings is a 
health care crisis, which requires broad national attention and 
the problem-solving efforts of individuals, organizations and 
government . 

Recent advances in transplantation surgery and immunology 
now provide the opportunity for additional years of life and health 
to many Americans who in the past were doomed to an existence 
supported by a machine, as in the case of victims of end-stage 
kidney disease, or were cut down by death prematurely, as in 
the case of people suffering from end-stage heart and liver 
disease. Other witnesses before this Subcommittee will provide 
substantive information to support my contention that medical 



136 



Testimony of DONALD W. DENNY p. 2 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology - 
U.S. House of Representatives 
April 13, 1983 



science has moved beyond the frontier in organ transplantation, 
has, indeed, reached a fertile high ground and needs but the 
active support and investment of this nation to establish a 
living monument to the value of human life and the spirit of 
brotherhood: the giving of life, one to another, on a large 
scale through organ transplantation. My focus today will be 
with one obstacle impeding realization of this bright promise: 
the shortage of human organs for transplantation that exists 
now and, unless nationwide efforts are undertaken, will in- 
crease tomorrow. 

The shortage of organs for transplantation is not a new 
problem. My colleagues and I have worked for years to overcome 
the fact that the demand for post mortem kidneys has long ex- 
ceeded the supply. The number of post mortem kidneys trans- 
planted in the United States has remained relatively stable for 
several ' years , despite the fact that the national waiting list 
has continued to grow annually. The shortage of kidneys for 
transplantation has received relatively little attention, 
largely because renal transplantation is not a form of trans- 
plant therapy which is often an alternative to death. We have, 
fortunately, the artificial kidney machine which can sustain 
life for most end-stage renal disease (ESRD) patients who elect 
to wait for a transplant, as well as those patients who do not 
wish to consider or are unsuitable for transplantation. The 
undeniable facts that a real kidney, a transplanted kidney, 
provides a better quality of life for ESRD patients and that 
renal transplantation is more cost-effective per patient 
life-year than the artificial kidney have not been sufficient 



137 



Testimony of DONALD W. DENNY p. 3 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Techno-logy - 
U.S. House of Representatives 
April 13, 1983 



to cause the national sense of urgency which underlies these 
hearings. Without intending to diminish the meaning and the 
importance of this Subcommittee's purpose today, I must lament, 
however, the fact that recent publicity concerning the need for a 
liver transplant for a handful of patients at two or three trans- 
plant centers (including my own) has outweighed the silent 
suffering of many thousands of patients waiting for a kidney 
transplant at 150 transplant hospitals over the past decade in 
moving the conscience of this nation. 

Yet, it is undeniable that liver and heart transplant can- 
didates, unlike kidney transplant patients, have only one other 
option: death. I cannot blame the media or the public for being 
more profoundly stirred by a picture of one sad-eyed dying child 
waiting and hoping for a liver donor than by cold statistics which 
represent the plight of faceless thousands of ESRD patients. We who 
spend our professional lives seeking donors of extrarenal organs 
(i.e., organs other than kidneys) have also been vulnerable to the 
poignancy of the individual child's desperate need. And when such 
a patient dies because an organ is not found in time, we also feel 
a crushing sense of sadness and failure. But we also feel 
something else, something the public generally does not, namely 
frustration and anger. The reason is that we know that many more 
organs are needlessly wasted than are recovered for transplan- 
tation. We know that the shortage of organs at this time is not 
due to a lack of technology, manpower, knowledge or funding, as 
much as it is due to ignorance, inertia, selfishness and parochialism. 



138 



Testimony of DONALD W. DENNY p. H 

Hearings on Organ Procurement and Distribution 
Investigations and" Oversight Subeommi-ttee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



We know, in short, that despite what one reads in the newspaper, 
there is a system in place in this country for the recovery of 
organs for transplantation, but that this system does not work as 
effectively as possible because of the lack of individual and 
institutional committment to the recovery of organs for trans- 
plantation . 

From February, 1981, through February, 1983, 126 post mortem 
livers were transplanted at the University Health Center of Pitts- 
burgh. During this same period, 44 adults and 27 children died 
before we found a suitable organ for them. During this same in- 
terval, 41 patients received heart transplants at our Center, but 
8 other patients succumbed to heart failure before we could trans- 
plant them. The success of liver and heart transplantation today 
is encouraging many more institutions to establish programs for 
the transplantation of these organs in order to meet the needs of 
increasing numbers of potential recipients. The problem promises 
to become worse. 

I need to define some limitations in order to express fully 
the nature of the problem. The post mortem recovery of vital or- 
gans for transplantation is limited by the circumstances of death, 
donor age, donor medical history, quality of organ function and 
temporal restrictions. Because vital organs are very vulnerable 
to lack of oxygenated blood at normal body temperature, we are 
unable to consider as donors of vital organs any individual whose 
death is determined by the traditional criteria, i.e., irrever- 
sible cessation of heart and lung functions. Organ death occurs 
within minutes of cessation of the circulation. Vital organ 



139 



Testimony of DONALD W. DENNY p. 5 

Hearings on Organ Procurement and Distribution 
Investigations and- Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



procurement is limited to patients who are medically and legally 
dead, but whose heart and lung functions are artificially main- 
tained with mechanical ventilation and intravenous hydration until 
the organs are surgically removed and chilled. In practice this 
means that organ donors must be victims of brain death, i.e., 
patients who have suffered catastrophic, irreversible and complete 
cessation of integrated brain function as the result of trauma, 
stroke, brain tumor and/or oxygen deprivation. The brain death 
syndrome by definition always includes destruction of brain stem 
function, among the sequelae of which is the total inability to 
breath spontaneously. Forty years ago before the development of 
the mechanical ventilator, which is used to take over respiratory 
functions for patients who have difficulty breathing or cannot 
breath spontaneously, death of the brain resulted in cessation of 
breathing and, secondarily, heart failure when the heart muscle 
died due to lack of oxygen. Use of the mechanical ventilator" has 
intruded upon this natural sequence of events and physicians have 
had to develop new operational criteria for determining when death 
has occurred in patients suffering from total and irreparable 
brain destruction. Pronouncement of death after determination of 
brain death is a commonplace event in the United States and is 
sanctioned by either statute or common law in all 50 states. Organ 
donation is not the primary or even secondary rationale for accep- 
ting brain death as death of the individual, but it is a necessary 
precondition for organ retrieval for transplantation. 



140 



Testimony of DONALD W. DENNY p. 6 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



Another limitation to donation is donor age. The inevitable 
consequences of aging, including vascular disease and the slow 
loss of optimum organ function, limits chronological age accep- 
table for donors. Kidneys are generally accepted from donors 
up to their mid-50's and sometime beyond. Liver donors are 
rarely considered beyond age 45; while heart donors are carefully 
evaluated if they are 35 and are seldom accepted beyond 40. 
Minimum age limits are also a factor. Kidney donors must gener- 
ally be one year or older. Liver donors can be accepted from 
age 6 months and up, however. Heart donors are seldom less than 
age 15. 

Other factors which can contraindicate organ donation 
include: previous disease involving the organ considered for 
donation, infection, cancer (except primary brain tumors) and 
acute injury to the organs due to trauma, oxygen depri-vation 
and persistent periods of low blood pressure. 

How many patients in this country's hospitals are victims 
of brain death and have suitable organs for transplantation? 
Again, no one really knows. Retrospective studies of hospital 
charts of patients dying in hospitals suggest between 0.77? and 
3-5? of hospitalized patients are acceptable as kidney donors 
(1, 2, 3). The difference in the conclusions is due to variations 
in acceptable criteria between investigators. (The percentage 
of potential donors in these studies which actually did provide 
organs for transplantation ranged from 17.0% to 19-03? (2, 3)- 

Since only patients who die in hospitals may be considered 
for vital organ donation, it is important to consider that only 
38$ to 60? of the deaths in this country occur in hospitals 



141 



Testimony of DONALD W. DENNY p. 7 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



(1, 2, 3). Assuming that half of the annual deaths in the United 
States occur in hospitals (which may be generous, since statistics 
on hospital deaths include patients who are dead on arrival and 
who expire in the Emergency Department soon after arrival), how 
many in-hospital deaths occur? In 1981, the last year for which 
statistics are available, there were a total of 1,987,512 deaths 
in this country (4), of which 50% is 993,756. Multiplying this 
figure by the above cited percentages of in-hospital deaths which 
would have been acceptable kidney donors, yields an estimated 
range of potential donors in the United States of 7,652 to 34,781. 
Because the age criteria for liver and heart donors is less liberal 
than for kidney donors, the potential number of extrarenal donors 
is undoubtedly fewer than is indicated by this range. 

How many donors annually yield vital organs for transplantation 
in the United States? One way of determining an approximation is 
by looking at the number of post mortem kidney transplants yearly. 
In 1981, the last year for which I have firm figures, there were 
3,^27 post mortem kidneys transplanted in this country. Since each 
donor yields two kidneys, dividing this number by two results in 
a figure of 1,713 donors. However, since there is approximately 
25? wastage of donor kidneys (as a result of surgical error, un- 
expected anomalies, no suitably matched recipients available), the 
total number of available kidneys during 1981 was approximately 
4,283, of which one-half or 2,141, represents the approximate num- 
ber of donors in that year. In other words, we are now recovering 
organs, at best, from fewer than one out of every three possible 
donors . 



23-029 0-83-10 



142 



Testimony of DONALD W. DENNY 

Hearings on Organ Procurement and Distribution 

Investigations and - Oversight Subcommittee 

Committee on Science and Technology 

U.S. House of Representatives 

April 13, 1983 



This figure does not represent the total number of potential 
donors referred to organ procurement programs. Organ donation is 
a voluntary activity in this country requiring consent of the 
nearest next-of-kin (a practical necessity for all organ procure- 
ment programs even when a donor has signed a donor card or other 
document allowing recovery of organs after death). Organ donation 
is unacceptable to some families and a percentage of prospective 
donors is lost for this reason. My experience is that approximately 
one out of five prospective donors referred to us does not yield 
organs for want of family consent. This figure varies around the 
country according to cultural, racial and educational character- 
istics of the population. Black families, for instance, are much 
less likely to donate than white families for reasons which are 
not understood. The number of families which elect not to donate 
is, however, somewhat larger, since an unknown number 'of potential 
donors are recognized by physicians, who approach the families and 
are refused, and never inform the local organ procurement program 
of their efforts. 

I value the fact that organ donation in this country is a 
voluntary, altruistic act determined by the values of the people 
concerned. National polls have indicated, however, that 70% and 
more of the people in this country regard organ donation favorably 
and would be willing to donate a family member's organs at the 
time of death (5, 6). I would be against legislation which would 
make donation either compulsory or subject to financial reward. 
Another option exists, one which is in practice in a few European 
countries, which is to assume that consent of the individual has 
been given for post mortem organ donation at the time of his 



143 



Testimony of DONALD W. DENNY p. 9 

Hearings on Organ Procurement and Distribution 
Investigations and- Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



death unless a document signed by the individual indicating 
opposition to donation is presented when he expires. Given the 
litigious climate of this country and the vulnerabli li ty of the 
medical profession in particular to nuisance suits, I doubt that 
this option is realistic. Even if such a system were legal, I am 
sure that surviving next-of-kin would also be asked to consent to 
recovery of the organs, even as they are now. 

Obviously, one means of increasing the numbers of organs 
donated would be to enhance the willingness of families to donate 
through educational programs. Educational efforts directed at 
the lay public have been an important component of many organ 
procurement programs' efforts for the past decade. Many approaches 
have been tried: professional advertising techniques (billboards, 
radio and television public service announcements, ads in newspapers 
and magazines), didactic presentations to students, churches and 
service clubs and news and feature stories released to the print 
and electronics media. While I am sure that these efforts have 
had an impact (some more than others), I am unaware of any reliable 
studies which can document the effectiveness of public education 
efforts tried thus far. I am personally biased in favor of the 
effectiveness of the free educational opportunities afforded by 
the media, although I have tried all the options cited above at 
one time or another. News and feature stories focusing on people 
with whom the public can identify reach the largest audience, 
have more emotional impact and require less financial investment 
than costly billboards, public service announcements, health fairs 
in shopping centers or classroom talks. Stories about patients 



144 



Testimony of DONALD W. DENNY p. 10 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



waiting for transplantation, about patients who have been success- 
fully transplanted, about individual donors and their families' 
feelings regarding donation have great human appeal. The media 
becomes quickly jaded, however, and one must constantly seek 
new "angles" with which to interest the press. 

Until recently, kidney donation and transplantation have 
been the primary thrust of public education for most procure- 
ment programs. One indication of the effectiveness of these 
efforts is the greater frequency with which the public is will- 
ing to donate kidneys as opposed to livers and hearts. The 
heart, of course, is a special case in view of the great 
symbolic and emotional investment traditionally associated with 
this simplest of all the vital organs. On the other hand, very 
little emotional attachment to the liver exists for most of us, 
and yet many families who are very willing to donate their 
family member's kidneys balk at donating the liver. The reason, 
I believe, is that liver donation and transplantation are not 
yet as well known and accepted as kidney transplantation. 

Most public education efforts in some way try to go beyond 
mere information giving and try to involve the audience in 
solving the problem by encouraging the completion and carrying 
of universal organ donor cards. Legislation has been enacted 
in all fifty states making such cards legal instruments for the 
post mortem donation of organs. As I have mentioned, however, 
all organ procurement programs with which I am familiar also 
require family consent, although legally it is not required if 
a donor card is available. The success of organ donor cards in 



145 



Testimony of DONALD W. DENNY 

Hearings on Organ Procurement and Distribution 

Investigations and Oversight Subcommittee 

Committee on Science" and Technology • 

U.S. House of Representatives 

April 13, 1983 



p. 11 



increasing the number of donor organs is minimal; relatively 
few donors each year are identified as card carrying donors. 
Our program has only one or two such donors each year out of 50 
to 60 donors in our region. The primary problem, I believe, is 
that our death is a very fearful prospect for most of us. We 
defend ourselves against this fear by avoiding any activity 
which tends to confirm our mortality. Completing and signing a 
donor card affirms our appointment with death and, as a result, 
most of us never get around to getting or completing a card. 
Like most other organ procurement programs, we distribute donor 

cards as many on 10,000 a year. This is not a large number 

compared to our region's population of approximately 3.5 million 
people, however. In Pennsylvania we have also had donor cards 
distributed with drivers' licenses for several years, yet our 
program has not seen an increase in card carrying donors as a 
result of this program. A recent survey in Maryland, where. the 
donor card is on the drivers' licenses, found that only 1.5% of 
the people chose to complete and sign the card (5). 

Organ donor cards do have some utility. Their availability 
stimulates discussion and contributes to a positive climate of 
awareness regarding the need for organs. Many times I have 
been told by donor families that receipt of a donor card with a 
driver's license engendered a family conversation, during which 
the deceased indicated his willingness to be a donor. These 
discussions are remembered at the time of death if organ donation 
is offered to the family, even though the deceased did not fill 
out the card. These families inevitably donate. 



146 



Testimony of DONALD W. DENNY p. 12 

Hearings on Organ Procurement and Distribution 
Investigations and- Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



I have always believed that public education should include 
the subject of brain death, as well as organ donation and trans- 
plantation. Many of my colleagues do not agree with me, believ- 
ing that the subject is too complex for the lay public to compre- 
hend or that there is a danger of brain death being misconstrued 
as so-called "transplant death". This latter possibility exists 
primarily because of the medical profession's hesitancy in edu- 
cating the public about brain death, a syndrome which is undoub- 
tedly clinically associated with many more non-donors than 
donors. If brain death is mentioned only in conjunction with 
organ donation, so the argument goes, the public will believe 
the syndrome is diagnostic of death only when the organs are 
sought, that brain death is not "real" death but a shortcut 
designed to make organ recovery possible. 

On the contrary, I find the public intuitively sophisticated 
and ready to comprehend that death of the brain is diagnostic" 
of death of the person if they are given accurate information 
and the discussion is in lay terms which they can comprehend. 
Not being candid about brain death and its relationship to 
organ donation is potentially very dangerous. If the public 
does not understand and accept it, they are much more likely to 
experience suspicion and disbelief when they are faced with it. 
We are all more ready to reject what we have not heard of or do 
not understand. 

Our emphasis on brain death education led us to seek enactment 
of legislation giving statutory recognition to brain death. 
Such legislation was not necessary to give legal standing to 
the syndrome as diagnostic of death, but was perceived as a 
means of educating the public. Public acceptance and passage of 



147 



Testimony of DONALD W. DENNY p.13 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science "and Technology • 
U.S. House of Representatives 
April 13, 1983 



the brain death bill also, we hoped, would reassure a medical 
community fearful of putative public inability to understand 
and accept brain death. Our program worked collaboratively 
with the other organ procurement program in the state, the 
Delaware Valley Transplant Program, Philadelphia, the Pennsyl- 
vania Department of Health, the Pennsylvania Catholic Conference, 
the Pennsylvania Medical Society and the Hospital Association 
of Pennsylvania in aggressively seeking passage of the Uniform 
Determination of Death Act during 1982. We conducted a vigorous 
letter writing campaign seeking medical professional and public 
support, sought and received press attention for the Bill and 
testified at legislative hearings in support of passage. This 
educational effort was very successful, surprisingly little 
opposition was encountered and the Bill was passed during Decem- 
ber, 1982. It is too early to tell whether or not the passage 
of this legislation will reassure the many physicians who hesi- 
tate to cooperate in organ procurement because of their fear 
that the public cannot accept death pronounced on the basis of 
destruction of brain function. 

Perhaps one of the less well recognized functions of public 
education is the impact it has on health professionals. Doctors 
and nurses are also media consumers and public education can help 
to persuade health professionals that organ procurement and brain 
death are acceptable to the general public. The health professions 
are generally conservative and frequently tend to follow rather 
than to lead public opinion. Yet, I am sceptical of the utility 
of costly advertising efforts as I have seen them employed in 



148 



Testimony of DONALD W. DENNY p. 14 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science" and Techno-logy - 
U.S. House of Representatives 
April 13, 1983 



this area in the past. Professionally produced public service 
announcements focusing on organ donation have almost always 
been directed toward the educated, white middleclass audience. 
Much more effective, I believe, would be programming and public 
service announcements directed toward segments of the population, 
i.e., working class ethnics, black Americans, Spanish-speaking 
Americans and other population subgroups. I feel that little 
is to be gained through educational efforts which do not employ 
the mass media; highly labor intensive public speaking campaigns 
directed toward schools and civic groups, for example, have 
little impact. The American Advertising Council does take on 
projects for non-profit organizations and activities. Perhaps 
this group of professionals could be prevailed upon to contribute 
time and talent to the production of effective mass market 
public education. 

Since, in my experience, approximately four out of five., 
families offered the opportunity to donate will decide favorably, 
I believe that the most effective allocation of current funding 
available would be to invest in the education and motivation of 
health professionals to recognize and refer potential donors. 
Despite very heavy favorable media attention .to organ donation, 
transplantation and brain death in the greater Pittsburgh area, 
no more than one out of ten donor referrals to our program is 
at the request of the family. The death of a loved one is so 
painful, the families are generally so preoccupied with their 
loss, that they do not think of organ donation. It must be 
offered to them . The role of the physicians and nurses who care 
for the patients and are in a position to recognize donors and 
to refer them to the local organ procurement programs therefore 



149 



Testimony of DONALD W. DENNY p. 15 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



becomes critical. The education of health professionals and 
the establishment of institutional policies which will enhance 
organ donation should, I believe, be the primary areas for the 
investment of time, energy and money. I must recognize, 
however, that many of my colleagues do not. agree with me. 

This is the philosophy which has been followed at both 
organ procurement programs with which I have been associated as 
Director. I joined the newly formed Transplant Foundation at 
the University of Pittsburgh School of Medicine in January, 
1978, after nearly four years with the Delaware Valley Trans- 
plant Program. Both programs were established at the outset as 
independent not-for-profit corporations governed by Boards of 
Directors composed of physicians closely involved with trans- 
plantation at associated university medical centers. Financial 
and corporate independence allows for flexibility in estab- 
lishing and implementing programs designed to achieve procure- 
ment goals. This Committee will hear evidence presented by 
other expert witnesses which strongly suggests that such inde- 
pendent organ procurement agencies are more economical and more 
successful than are programs which are functions of hospitals 
or universities. 

In describing the philosophy and the programs which I have 
found successful in organ procurement, I will focus on the 
Transplant Foundation at the University of Pittsburgh and our 
efforts during the past five years. Although kidney transplan- 
tation had been initiated by the University's School of Medicine 
in 1964, the program had remained relatively small until it was 



150 



Testimony of DONALD W. DENNY P-16 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology - 
U.S. House of Representatives 
April 13, 1983 



reorganized in 1977 under the direction of Thomas R. Hakala, 
M.D. Growth of the transplant program had not been limited by 
the number of patients referred for renal transplantation, 
witness the fact that almost 100 ESRD patients were on our 
waiting list in late 1977. Instead, the major handicap had 
been the shortage of available kidneys. Until 1978, the Univer- 
sity was entirely dependent upon kidneys which could be recovered 
at the University Health Center of Pittsburgh or could be imported 
from other centers in the nation. No organized effort existed 
to seek the collaboration of other area hospitals in recognizing 
and referring donors. In the fourteen year history of the 
renal transplant program at Pitt prior to 1978, only one donor 
had provided organs at a hospital outside the University Health 
Center. Clearly the community hospitals offered an untapped 
source of organ donors. 

Two major programs were planned and implemented during. . 
1978 for developing organ procurement at approximately 90 hospi- 
tals in a geographic area including western Pennsylvania, eastern 
Ohio and northwestern West Virginia: (a) an educational program 
for health professionals and (b) a comprehensive organ retrieval 
program, which would provide 24 hours-a-day services for the 
coordination of the donation process and for the surgical re- 
trieval and preservation of donor kidneys in outlying hospitals. 

The educational program emphasized dissemination of infor- 
mation concerning the need for kidneys, donor criteria, evalua- 
tion and management, the medicolegal aspects of donation and 
brain death, the psychology of grief and its effect on organ 
donation, the surgical techniques of organ retrieval and the 
services provided by the Transplant Foundation team. I was 



151 



Testimony of DONALD W. DENNY p. 17 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



given responsibility for implementing this program. 

We followed a five-step plan. First, the need for educa- 
tional materials was recognized and appropriate brochures, posters, 
phone stickers and handbooks were developed. Secondly, a direct 
mail campaign utilizing personal letters and follow-up phone calls 
was initiated to establish contact with physicians in influental 
positions within area hospitals for the purpose of scheduling 
educational programs. Third, presentations were scheduled and 
carried out at meetings of medical staffs, critical care nurses 
and hospital administrators. Fourth, in those hospitals in which 
contacts could not be made with supportive staff through mail and 
phone efforts, I sought cooperation and speaking opportunities 
through unscheduled individual contacts with key hospital personnel 
Fifth, follow-up personal contacts were planned and carried out 
on a regular basis to strengthen and maintain the level of aware- 
ness and to facilitate the formation of strong purposeful rela- 
tionships with important keystone professionals. 

We have continued to follow this program throughout the past 
five years. Experience has proven the value of personal contacts 
through phone, mail and direct visits with physicians and nurses 
in critical care areas. Too frequent contact can be interpreted 
as unwarranted invasion of professional responsibility, whereas 
very infrequent contacts do not maintain the visibility for organ 
donation we strive to achieve. We find that contacts approxi- 
mately four times a year are most effective. An effort is made 
to enhance identification of these health care professionals 
with our program through the distribution of inexpensive calendars, 



152 



Testimony of DONALD W. DENNY P-H 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology - 
U.S. House of Representatives 
April 13, 1983 



penlights, pens and other items with our logo, name and telephone 
number. Personnel changes in area hospitals frequently necessi- 
tate repeat educational programs. 

Our efforts to acquaint physicians and nurses with our need 
for organs and to excite them about the possibility of coopera- 
ting with us were and are today met with a variety of responses. 
Many health professionals were warmly receptive, hungry for infor- 
mation and eager to assist for purely humanitarian reasons. Many 
others were indifferent and unresponsive or aloof and unwilling 
to help because of perceived medicolegal problems. A few were 
interested in helping because they anticipated that cooperation 
would possibly be used to their benefit politically. If their 
needs were not met, they quickly lost interest. And, finally, 
a very few were openly hostile; more than once I was summarily 
ejected from a hospital or told that I was presumptious for seek- 
ing cooperation in establishing our donor program in a hospital. 
One becomes rather thick-skinned and if one approach does not work 
there are usually other approaches which can be taken. Almost 
always we can find someone in a given hospital who is interested, 
receptive and helpful. What I want to emphasize, however, is 
that the direct humanitarian appeal is sometimes not effective 
in securing cooperation of health care professionals. 

Health care is not unlike other areas of human endeavor in 
that it is affected by politics, power struggles, inertia, fear, 
vanity and money. Motivation is often, but not always, complex, 
and frequently includes factors other than a desire to help 
others. Development and the growth of a donor program must re- 
cognize and accept this reality and, if possible without compro- 
mising individual and program principles, work with it or, if 
necessary, work around it. 



153 



Testimony of DONALD W. DENNY p.19 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Techno-logy - 
U.S. House of Representatives 
April 13, 1983 



The most important inducements which are effective are the 
solace organ donation provides the health professional and the 
humanitarian appeal of helping others, both the donor family 
and the transplant recipients. Health professionals, like all 
of us, dislike failure. The death of a patient is an assault 
on their feelings as caring people and an affront to their 
professional competence and identity. Their tendency in the 
face of patient death is often to attempt to distance themselves 
emotionally from the pain of failure. What we can offer doctors 
and nurses is a way of diminishing pain of failure. We do not 
put it that way to them, of course. We talk instead of the 
lives of the recipients which can be saved and the solace the 
family can realize through transplantation of the donor's organs. 
There is genuine satisfaction for a physician or nurse in help- 
ing both the family and the recipients through participating in 
organ donation, but what most get out of the experience, I 
believe, is a restoration of their own self-regard and emotional 
equalibrium. Participating in organ donation tends to diminish 
their sense of loss and failure. But, again, for some this is 
not enough. And for a very few, nothing appears to be enough 
to secure their active involvement. 

The personal relationship developed between the representa- 
tive of the organ procurement team and physicians, nurses and 
other hospital staff is also a major factor in developing an 
organ procurement program. In our program, the organ procurement 
coordinators (there are now four of us) are the most visible of 
the team members. We make initial contacts, provide the educa- 
tional programs for doctors and nurses, receive donor referrals, 



154 



Testimony of DONALD W. DENNY p. 20 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



collaborate on-the-scene throughout the entire donor process 
(evaluation, management, discussions with family, surgical re- 
moval of the organs), call, write and return in person to provide 
feedback about the transplant outcome. In the process we strive 
to develop a relationship based on trust, collaboration, recog- 
nition, personal regard and shared experience. The strength of 
the relationship enhances and sustains other motivational factors 
which may be operational. 

Nothing succeeds like success, however, and a positive ex- 
perience of being involved in recovering organs from a donor is 
very reinforcing for most physicians and nurses. Their sense of 
satisfaction almost always guarantees their future support. But, 
in order to provide this kind of positive experience, the entire 
process must be handled efficiently, tactfully and knowingly from 
beginning to end. The second major component of our program, the 
system for coordinating the donor process and recovering the' or- 
gans is based on our belief that only transplant professionals 
have the time, committment and attention to detail which are 
necessary to ensure that the experience and the outcome are both 
positive. Some organ procurement programs appoint a nurse or phy- 
sician on the staff of a community hospital to coordinate organ 
donation in that institution. Some programs also train local non- 
transplant surgeons to remove kidneys for shipment to the trans- 
plant center. We feel that reliance on indigenous health profes- 
sionals is fraught with too many opportunities for error, misun- 
derstanding and omission of important procedural steps. The organ 
donor process from beginning to end is a very complex one, in- 
volving critical clinical, medicolegal and psychological variables. 



155 



Testimony of DONALD W. DENNY p. 21 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science" and Technology - 
U.S. House of Representatives 
April 13, 1983 



Problems, when they occur, need to be handled expeditiously and 
sensitively. If they are not the concept of organ procurement 
suffers and the enthusiasm for cooperating with our program is 
damaged. For these reasons, we believe it is necessary to have 
one of our coordinators present in the donor hospital whose sole 
purpose is to make the donation process work. Similarly, in the 
Operating Room our transplant surgeons are responsible for per- 
forming the donor surgery. The techniques are specialized and 
not understood by untrained surgeons. Additionally, the trans- 
plant surgeon's committment to a positive experience for the 
donor hospital's staff and the recovery of viable organs is more 
focused because he knows that the success of his program and the 
well-being of his recipients is directly at stake. 

In summary, the establishment and success of an organ pro- 
curement program is not an enterprise which lends itself to a 
mechanistic or bureaucratic approach. As with any endeavor 
which requires collaboration of people from disparate professions 
with differing agendas and dissimilar institutional loyalties, 
organ procurement requires constant attention to the establish- 
ment, maintenance and repair of a delicate fabric of relation- 
ships, as well as dissemination of substantive information and 
technical competence. 

Yet, no program is so successful that it can sustain itself 
solely with the organs recovered in its immediate region. Organ 
sharing between 110 organ procurement programs has developed 
over the past dozen years in response to need and technical 
capabilities. Fully half the kidneys transplanted today have 
been surgically recovered by distant procurement programs and 



156 



Testimony of DONALD W. DENNY p. 22 

Hearings on Organ Procurement , and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



transported to the transplanting center. Kidney sharing is facil- 
itated by our technical ability to preserve these organs for 48 
hours and sometimes longer. Since kidney transplantation is 
seldom if ever life-saving therapy and since, until recently, 
demonstrably improved transplant survival occurred when attention 
was given to matching donor and recipient tissue types, the shar- 
ing of kidneys on the basis of computer matching of immunologic 
factors has been enthusiastically supported by almost all centers. 
The United Network for Organ Sharing (UNOS) is an informal network 
of approximately 130 transplant and organ procurement programs 
which register their patients waiting for renal transplants on a 
central computer owned and operated by the South-Eastern Organ 
Procurement Foundation (SEOPF) in Richmond, Virginia. SEOPF itself 
is a regional cooperative organization of 39 transplant programs, 
although its computer provides nationwide services for distribu- 
tion of kidneys. The concept of computer matching for kidneys 
must not be misunderstood to mean that the computer directs the 
placement of that available kidney. Instead the computer merely 
sorts through the thousands of potential recipients to identify 
those which appear to be suitable matches. The sending center 
then selects the recipient center(s) to which it may wish to 
offer the available organ, contacts that center by phone and makes 
arrangements to transport the kidney if it is acceptable. Sharing 
of kidneys is not infrequently influenced by non-immunologic 
factors, such as the proximity and close relationship between 
sending and receiving centers. 



157 



Testimony of DONALD W. DENNY p. 23 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science' and Teehno-logy - 
U.S. House of Representatives 
April 13, 1983 



The emergence of extrarenal organ transplantation as an acceptable 
therapy for end-stage heart and liver failure patients has in 
the past few years resulted in a modification of this informal 
organ sharing effort: the collaboration of two or three programs 
in surgically recovering organs from a single donor. In this 
form of sharing the donor is identified in a regional hospital 
of one program. The host program is almost always eager to 
recover the kidneys, but has no use for the extrarenal organs. 
Rather than see the organs wasted, the host program invites one 
or two other procurement programs in need of extrarenal organs 
to fly to the donor hospital for the purpose of retrieving the 
heart and/or liver. In this model the on-scene coordination of 
all clinical, medicolegal and logistics aspects of the donation 
process are handled by the host program coordinator. Telephone 
communication between the host coordinator and his colleagues 
from the extrarenal center(s) facilitates the carrying out of 
specialized requirements for the extrarenal centers prior to 
the convergence of all of the teams in the donor hospital 
Operating Room. All of the programs participating :n organ 
recovery share in assuming the responsibility for the costs. 

The Transplant Foundation at the University of Pittsburgh 
did not initiate intercenter collaborative organ retrieval 
(that distinction belongs to the University of Colorado and the 
Medical College of Virginia), but it unquestionably has the 
most experience in this form of organ (or, more properly, donor) 
sharing and has developed the system far beyond its early stages. 



158 



Testimony of DONALD W. DENNY p. 24 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science- and Technology 
U.S. House of Representatives 
April 13, 1983 



This form of intercenter collaboration was first ittempted by 
Pitt in 1980 with the inauguration of our cardiac transplant 
program and has become a commonplace activity during the past 
two years with the relocation of the nation's largest liver 
transplantation program to Pittsburgh. Our program was unable 
to generate sufficient numbers of donors for heart and liver 
transplantation within our own region and necessarily turned to 
other programs with a request for help. The need for help from 
other programs is not just a function of the number of available 
donors locally. We have a rather large donor program and annually 
recover kidneys from 50 to 60 donors in our region. For several 
reasons, an available donor may not be suitable for heart or 
liver donation. First, patients accepted for heart and liver 
transplantation are terminal and will die within days or weeks 
unless successfully transplanted. There is often no time to 
wait for a local donor. Secondly, unlike kidneys, heart and 
livers must come from size compatible donors. Especially in the 
case of pediatric recipients, this presents a major problem' 
since relatively few small children succumb to brain death. 
Our liver transplant waiting list now includes over 30 potential 
pediatric recipients under the age of five years. Intercenter 
collaboration is imperative especially for these youngsters. 

Our experience in seeking the cooperation of other procure- 
ment programs recapitulated our experience in asking for the help 
of hospitals in our own area. A few programs enthusiastically 
came to our aid immediately, most were suspicious and slow to 
respond and a very few were indifferent or hostile and totally 



159 



Testimony of DONALD W. DENNY p. 25 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Techno-logy - 
U.S. House of Representatives 
April 13, 1983 



uncooperative. The primary concern initially voiced by our 
colleagues at other programs was their fear that the surgical 
technique required for extrarenal procurement would jeopardize 
the quality of their donors' kidneys. This is not true but time, 
persistence and published data were required to convince many 
initially reluctant programs. We still find that there are many 
organ procurement programs within the eastern half of the United 
States which are unwilling to collaborate with us in the recovery 
of extrarenal organs. Some of these programs are merely insular, 
some are unwilling to help because of the extra effort required 
and some are reluctant to work with us because they fear our 
involvement will somehow compromise their own procurement efforts. 

Although intercenter collaboration was difficult for us to 
establish, the concept has become increasingly popular. The 
statistics reveal our success. During 1981, we received 175 
referrals of extrarenal donors from other programs and were able 
to recover 20 livers and 9 hearts in cooperation with distant 
renal procurement teams. In 1982, we received over 520 referrals 
from other programs and recovered 63 livers and 18 hearts with 
outside help. Three-fourths of the livers and four-fifths of 
the hearts transplanted at the University Health Center were 
recovered through the generous collaboration of other regional 
procurement programs. We are proud, too, that Pittsburgh is 
also a major provider of extrarenal organs to other centers. 
When we are unable to utilize an available extrarenal organ from 
a donor in our region, we always seek to work collaboratively 
in the recovery of these organs with other programs in need. 



160 



Testimony of DONALD W. DENNY p . 26 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology • 
U.S. House of Representatives 
April 13, 1983 



One of the major factors which aided us in developing inter- 
centet cooperation was the opportunity for communication and the 
development of trust afforded by the professional association of 
organ procurement coordinators, the North American Transplant 
Organization (NATCO). Workshops on extrarenal organ procurement 
sponsored by NATCO provided an opportunity for concerns to be 
discussed and resolved. NATCO's annual training course for pro- 
curement coordinators provides intensive orientation through 
extrarenal procurement for new procurement personnel. 

NATCO has also been a major force for the sharing of extra- 
renal organs. The major system used by procurement personnel to 
locate recipients for available extrarenal organs is sponsored 
by NATCO. At this time, approximately 17 transplant centers are 
involved in extrarenal organ transplantation in the United States 
and Canada. This number will become swollen during the next 
several months when at least five additional centers will inaug- 
urate heart transplant programs and another six centers will 
begin transplanting livers. Last year, NATCO recognized the 
problem faced by organ procurement personnel in locating suitable 
recipients for extrarenal organs which may become available in 
local community hospitals. The UNOS computer system has great 
utility in helping to distribute kidneys, but is much less 
effective in the area of extrarenal organ sharing. Because of 
very limited capability for preservation of extrarenal organs 
(hearts can be preserved for no more than 4 hours and liver for 
approximately 10 hours), these organs cannot be removed from 



161 



Testimony of DONALD W. DENNY p. 27 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science' and Techno-logy • 
U.S. House of Representatives 
April 13, 1983 



the donor before a suitable recipient is identified. Transplan- 
tation must occur immediately after the donor surgery. Size, 
blood type compatibility, geographic distance and urgency of 
need are the primary factors considered in coordinating recip- 
ient selection of extrarenal organs. Procurement coordinators 
who receive a donor referral during non-office hours or who are 
evaluating a donor at a community hospital and wish to discuss 
extrarenal donation with the donor family cannot access the 
UNOS computer to review current extrarenal needs" across the 
country. NATCO recognized the problem and established a 24 
hour-a-day telephone service for informing organ procurement 
programs of extrarenal needs. This free, volunteer service 
utilizes a recorded message system which can be accessed from 
any phone in the United States or Canada. Updated as needed 
(usually once or twice a day) the recording lists by center the 
type of organs needed, a priority status code indicating urgency 
of recipient need, the donor criteria (size, weight, blood 
type), geographic limitations to procurement, the name of the 
procurement coordinator to be contacted and the phone number of 
each participating extrarenal center. Fifteen extrarenal centers 
now use the system to acquaint organ procurement programs with 
their donor needs. 

During the first, six months of service, the NATCO 24-ALERT 
System (the name is taken from the System's mnemonic phone 
number) facilitated the recovery and transplantation of 30 
hearts at 9 centers, 48 livers at 5 centers and 1 heart-lung 
bloc. Success of the 24-ALERT System and temporal limitations 
which prevent heart and liver procurement much beyond 1,000 miles 



162 



Testimony of DONALD W. DENNY _ P- 2 * 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



from an extrarenal center have prompted NATCO to plan to divide 
the System into two complimentary geographic components. Within 
the next month a 24-ALERT WEST will be established to handle the 
western half of the country, while the original System will con- 
tinue to convey information of relevance for the eastern half 

of the nation. 

The System is not perfect but it works better than anything 
else available at this time. The UNOS computer, in fact, is used 
only infrequently for extrarenal organ sharing because of the 
greater effectiveness of the NATCO 24-ALERT System. As is the 
case with the UNOS computer program for kidney sharing, the 
current System provides information to the donor program staff 
and leaves up to them the decision concerning which extrarenal 
program is to be contacted. Undoubtedly some extrarenal programs 
are often not contacted because of factors unrelated to the 
urgency of their need. Center-specific problems with the quality 
of their procurement services are a major impediment, for example, 
for some extrarenal programs. No distribution system will be 
effective which attempts to compel cooperation between programs 
which do not trust one another. 

Inter-regional extrarenal procurement is expanding rapidly. 
The University of Pittsburgh alone has worked cooperatively with 
over 40 other organ procurement programs during the past two 
years. On 12 occasions we have participated with two other pro- 
grams in simultaneously recovering organs from a single donor. 
At this time the necessary trust in the technical competence of 
other transplant surgeons which would allow distant procurement 



163 



Testimony of DONALD W. DENNY p. 29 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Techno-logy - 
U.S. House of Representatives 
April 13, 1983 



and sharing of extrarenal organs (rather than donor opportunities) 
is not well developed; most extrarenal transplant surgeons still 
desire to have donor organs removed by members of their own team. 
With experience and time, however, this inhibition will be over- 
come and hearts and livers will be exchanged as kidneys are now. 

One major problem will probably continue to exist for the 
foreseeable future. Because of the delicate nature of lung tissue, 
long distance procurement of heart-lungs and single isolated lungs 
now require the tranportation of the donor from the donor hospital 
to the center where transplant surgery will be performed. Recent 
success with the transplantation of heart-lung blocs warrants 
continued efforts in the transplantation of these organs. The 
willingness of most organ procurement programs to transport a 
local donor hundreds or thousands of miles to an extrarenal 
center for the recovery of heart-lungs or isolated lungs is 
strongly inhibited at this time by the fear of the procuring 
program that the quality of the kidneys will be jeopardized. 
Another factor limiting the availability of these organs is that 
many families which are willing to donate are unwilling to subject 
their loved ones to transportation to the donor center for organ 
retrieval. The University of Pittsburgh and Stanford University 
have the only heart-lung transplantation programs in the United 
States and both are seriously compromised in their ability to 
offer heart-lung transplantation to the many candidates for this 
surgery because of the shortage of suitable donors. Montefiore 
Hospital, New York City, has a similar problem in developing their 
lung transplantation program. 



164 



Testimony of DONALD W. DENNY p. 30 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science" and Techno-logy - 
U.S. House of Representatives 
April 13, 1983 



The current system for the procurement and sharing of kidneys 
and extrarenal organs is essentially sound, I believe. The exist- 
ing system of regional procurement programs is in principle the 
most effective means of cultivating the growth of donor programs 
at the community hospital level. Regionalization facilitates 
the personal contacts which are essential and regional idiosyn- 
crasies are best recognized and responded to on a regional basis. 
Inter-regional collaboration will continue to grow as need and 
familiarity with the benefits of donor and organ' sharing increase. 
Yet the fact that no more than one-third of the potential donors . 
in this nation now yield organs for transplantation indicates 
that the system for organ procurement at the regional level needs 
strengthening, especially at its weakest point: the interface 
between the organ procurement programs and the health professionals 
in the community hospitals who are in a position to recognize 
and refer donors. I have the following recommendations: 

(J . ) It is time that transplant and organ procurement profes- 
sionals seek the help of others outside the transplant 
community. A national task force should be formed of 
representatives of organ procurement and transplant 
specialty groups and other significant health profes- 
sionals' organization to identify problems inhibiting 
referral of organ donors to regional programs and to 
recommend solutions on a national level. Such a task 
force should include leaders from organizations which 
represent physicians and nurses likely to encounter 
donors, i.e., neurosurgeons, neurologists, critical 
care physicians, emergency physicians, pediatricians, 



165 



Testimony of DONALD W. DENNY p. 31 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Technology 
U.S. House of Representatives 
April 13, 1983 



critical care nurses, as well as leaders from organ- 
izations of hospital administrators and other relevant 
groups . 

(2.) Rules and regulations should be enacted on the state 
and/or national level which would require that every 
hospital seeking certification (a) enact a policy and 
operational protocol for the determination of brain 
death; and (b) develop a policy and protocol for the 
recognition and referral of potential organ donors to 
the nearest regional procurement program. (In Pennsyl- 
vania, with the support of the Secretary for Health, 
efforts are now underway to have both of these regula- 
tions adopted by the State Department of Health as 
requirements for hospital certification.) 

(3-) A financial incentive should be built into the federal 
Medicare reimbursement system which would reward hospi- 
tals from which post mortem donor kidneys are recovered 
for transplantation. No new legislation should be re- 
quired, since Medicare now funds renal transplantation 
and kidney procurement. This should be especially 
attractive to the taxpayers and the federal government 
since kidney transplantation is considerably less ex- 
pensive than chronic dialysis. (Most post mortem kid- 
ney donors are also potential extrarenal donors and 
this incentive system would also enhance opportunities 
for extrarenal organ procurement.) 



166 



Testimony of DONALD W. DENNY P-32 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science and Techno-logy - 
U.S. House of Representatives 
April 13, 1983 



(4.) Areas of this country still exist which provide few if 
any organs for transplantation. The problem in part is 
the failure of the regional organ procurement programs 
effectively to educate physicians and nurses. Streng- 
thening education for health professionals is essential. 
One step in this direction has recently been taken by 
NATCO, which has established a 24 hour-a-day organ 
donor information and referral hotline for doctors, 
nurses and other hospital staff who have questions 
about donation or want to refer potential donors but do 
not know how to contact their local procurement program, 
Staffed by trained organ procurement coordinators, the 
hotline (dial 800/24-DONOR ) needs wide exposure in the 
medical community to be effective. Support for this 
and other efforts to strengthen professional education 
is sorely needed. 

(5.) Public education efforts should be stepped up, with 
emphasis given to developing mass media educational 
opportunities focused on subgroups of the population. 
The National Advertising Council should be asked to 
take on a national project for public education. 

(6.) My final suggestion is one which should be self- 
evident from my testimony. There is a real need for 
the accumulation of data on organ donation, organ dis- 
tribution and transplantation. Some data is now 
collected on renal donation and transplantation by 
the Health Care Financing Administration, but no 



167 



Testimony of DONALD W. DENNY p. 33 

Hearings on Organ Procurement and Distribution 
Investigations and Oversight Subcommittee 
Committee on Science" and Technology - 
U.S. House of Representatives 
April 13, 1983 



figures are available for the country as a whole con- 
cerning the number of potential donors, the number of 
potential donors referred to organ procurement programs 
but from whom organs are not recovered, the number of 
extrarenal organs needed, recovered and transplanted. 
Some very practical questions need to be answered. 
For instance, how many suitable pediatric donors between 
the ages of six months and five years are potentially 
available? The number of small children being referred 
for liver transplantation is growing geometrically; we 
may be faced with the fact that there will never be a 
sufficient number of younger donors to meet the need. 
We won't know unless we investigate. 



168 



Testimony of DONALD .W. DENNY _. 

Hearings on Organ Procurement and Distribution 

Investigations and Oversight Subcommittee 

Committee on Science and Technology 

U.S. House of Representatives 

April 13, 1983 



BIBLIOGRAPHY 

(1 ) Cooper, K.D., et al , "The Potential Supply of Cadaveric 

Kidneys for Transplantation", Transactions of the American 
Society of Artificial Organs , vol. 23, pp. 416-421 (1977) 

(2 ) Proj ect to Reduce Waiting Times for Cadaveric Kidney 

Transplants in Michigan: Phase I Final Report , Transplan- 
tation Society of Michigan (1982) 

(3 ) Barb K.J., et al, "Cadaveric Kidneys for Transplantation:. 
A Paradox of Shortage in the Face of Plenty", Transplan- 
tation , vol 35, no. 5, (1981) 

(4.) Statistical Abstracts of the United States , Department of 
Commerce, Bureau of the Census, 1982-1983 

(5.) Council on Scientific Affairs of the American Medical .. 
Association, "Organ Donor Recruitment", Journal of AMA , 
. vol 246, no. 19, (1981), p. 2157 

(6 ) Gallup Organization, Inc., Attitudes and Opin ions of the 
American Public Toward Kidney Donation, (prepared for the 
National Kidney Foundation, Inc., New York), Princeton, N.J. 
(1983) 



169 

Mr. Gore. Thank you very much, Mr. Denny. I commend your 
entire remarks to the attention of those reading this record and 
your recommendations will no doubt, many of them be included in 
the subcommittee's report. 

Dr. William Pfaff, past president of the South-East Organ Pro- 
curement Foundation at the University of Florida College of Medi- 
cine in Gainesville, and a noted kidney transplant specialist in his 
own right. We are delighted to have you here. 

Please proceed. 

4.iP r v Pf £ f £- Than k you. I was asked to appear today to describe 
the bouth-East Organ Procurement Foundation [SEOPF]. SEOPF 
actually has been enlarged from its original membership of eight to 
some 40 members. 

Those of you who live north of here will be surprised to learn 
that New Jersey is also in the Southeast, as is Indiana. So the 
rough boundaries 

Mr. Gore. We are an ambitious region. 

Dr. Pfaff. The rough boundaries are New Jersey to Indiana 
Louisiana to Florida. Almost all of the programs that are trans- 
planting and procuring organs in this areas are members of our 
foundation. 

SEOPF was established with the hope and expectation that 
tissue typing and tissue matching would result in improved graft 
survival. That was the first premise. 

Second, there was a realization that an excess of supply at one 
site might coincide with a need at another site, that there was an 
advantage to mutual education and a discipline that was dramati- 
cally unfolding. Finally, there was a need for uniform tissue typing 
laboratory practices. As the organization has matured, it has con- 
tinued to work at these goals, and then has established some others 
in a variety of activities. 

The current means of exchange is heavily dependent upon our 
computer network. We list, from the members alone, something in 
excess of 2,200 patients. 

Approximately one-third of the patients who are being trans- 
planted in the country receive their grafts among this membership 
ol some 40 institutions. 

The means of distribution of kidneys is principally on the basis 
ot tissue typing characteristics. We are trying to take advantage of 
the immunology that we have gradually uncovered over these 
years in order to provide a more successful graft, for there are 
some individuals who absolutely need a well-matched transplant in 
order to be successfully managed. 

The computer network distribution system has been expanded to 
™ e rest of the country, and the organization that is an outgrowth 
of the SEOPF technology is called UNOS [the United Network for 
Organ Sharing.] 

Now some 138 transplant programs nationwide, thus, are using 
this single means of distributing kidneys. When I left Gainesville 
yesterday, on the plane with me there was a kidney that was des- 
tined for Minnesota. Another had left on the earliest plane from 
Gainesville to go to Mississippi. By the same token we expect that 
Minnesota is going to return the favor for the same purpose, 
namely, to provide, again, a well-matched organ. 



170 

In practical terms if a kidney becomes available at the Universi- 
ty of Florida or one of our nearby hospitals — we are in a semirural 
area — that we tissue type the donor, look at the computer readout 
and first priority, and that is to distribute the well-matched organ, 
irrespective of local need. 

We run the computer program and identify the potential recipi- 
ents who are listed in priority of their organ matching characteris- 
tics and then call the appropriate center. Each of the centers have 
24-hour numbers and 24-hour personnel to advise them of this 
opportunity. 

The level of activity of SEOPF members, included 604 kidney 
transplants from July 1 through December 31, 1982. During the 
same time period, half again that number of organs were procured. 
In other words, the transplant rate is 1,200 per year, the procure- 
ment rate is 1,800 per year. Thus there is an excess that is generat- 
ed within the region and that is distributed to non-members as the 
net of about 250 or 260 excess kidneys per year. 

The total incidence of sharing amongst the donating centers is 
some 59 percent. The majority of the kidneys that are procured in 
the Foundation are shared with other centers, both within and 
without the Foundation. 

The other areas in which we have become interested in is scien- 
tific data. Somewhere along the line we needed to find out what we 
were doing. The points that Mel Williams made to you earlier 
today regarding the five factors that have import and the varied 
success of transplantation are factors that have been covered, 
uncovered, sustained and demonstrated individually in other 
programs. 

All of that information was generated within one program and 
that was from the cooperative efforts of the SEOFP membership, so 
that we achieved some specific knowledge about transplantation, 
about organ preservation, sharing, and procurement as a conse- 
quence of sharing our information. 

In 1973, with the institution of the medicare law that covered 
renal failure, the funding for the voluntary registry that trans- 
plant programs have maintained for a good number of years 
ceased. 

We were promised a medical information system. That has never 
happened. The only sources I have for making decisions about pa- 
tients are the SEOPF data that addresses only transplant patients 
and my local network, that is, the Florida End-Stage Renal Disease 
Network. We have excellent data on every dialysis and transplant 
patient in the State of Florida. I know the relative risks of dialysis 
and transplantation, of different modes of transplantation, as that 
is expressed in age, causative diseases and also associated diseases. 

I would urge those of you who are interested in having informa- 
tion available to make such decisions that you reconsider the ef- 
forts that have been suggested in some areas of our own Govern- 
ment to cease funding of the networks. To me, it would be 
crippling. 

Transplantation of heart, liver and pancreas is varied in this 
country, rapidly growing. You heard a number of people describe a 
number of existing programs. 



171 

Frankly, within our own foundation we have not kept up with it. 
We have not established a program for sharing these organs. We 
cannot address the costs of distribution of other organs, at least as 
an addition to the elements of exchange to the End-Stage Renal 
Disease Program. We would have to establish some other form of 
funding to do that, because of the disallowance you have heard dis- 
cussed earlier today. 

Can the basic system be used for organ exchange? Yes. The 
means by which we exchange organs really is adaptable, I think, to 
almost any organ. 

There are differing needs in terms of the ability to maintain the 
organ outside the donor, even in using the preservation techniques 
we have today. The heart is very urgent, the pancreas, perhaps, the 
most urgent of all. It appears that the liver can be preserved for at 
least a number of hours. The kidney, can be sustained for 1 to 3 
days. Each of those developmental problems of organ preservation 
is going to put different kinds of restrictions on us in terms of both 
procurement and, most importantly, sharing of organs. 

Yet we come to that subgroup of our patient populations who ab- 
solutely need a well-matched organ in order to be successfully 
transplanted, and we need to address that question as we proceed. 

We are increasing our success at all forms of transplantation. 
Each one of us looks at our own program and questions. "Have we 
done better this year?" We are proud if we have; we are disappoint- 
ed if we haven't — we are dashed if we haven't. 

The economics of transplantation are a matter of continued con- 
versation in your sphere and in ours. For these new areas we don't 
have a solution. We have come to you for a solution. We need to 
expand this dialog, from successful kidney transplantation to in- 
creasing success in other areas. 

The problems, as I see them, are identification of additional 
appropriate transplant recipients. That is based on the delivery of 
sound, scientific information, both to patients and to other 
professionals. 

I think that you have heard that often enough. I would not reit- 
erate further. 

We are doing a good job of kidney procurement in our area of 
the country. I think we are doing a fairly good job in terms of extra 
organ procurement. 

I would ask whether that is the product of our cooperative work, 
of our group effort, of our mutual pride, because I think that that 
is something that might be exported to other areas of the country. 

There are very few large regional organizations. They tend to be 
metropolitan or a small area. Yet, much of our ease of working 
with one another has been through sera exchange, through the his- 
tocompatability laboratories and through our computer network. 

I would favor expansion of the regional concept with interre- 
gional cooperation. We have some patients who have uncommon 
blood type, uncommon tissue types and their opportunity for a 
matched graft even within our rather sizable program may be in- 
frequent. Thus, expansion of the number of cooperating centers 
will expand the potential for cross-matching between donor and re- 
cipient, we will have a much better likelihood of getting these long- 
waiting individuals a successful transplant. 



172 

Thank you. 

Mr. Gore. Thank you very much. 

[The prepared statement of Dr. Pfaff follows:] 



173 
Testimony of William Pfaff, M.D., Concerning Organ Sharing Transplatation 

SUMMARY OF TESTIMONY OF WILLIAM W. PFAFF, M.D. 

CONCERNING ORGAN SHARING IN TRANSPLANTATION 

PRESENTED TO THE 

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT 

COMMITTEE ON SCIENCE AND TECHNOLOGY 
UNITED STATES HOUSE OF REPRESENTATIVES 

APRIL 13, 1983 
The success of transplantation can be improved by inter-institutional 
cooperation. The Southeastern Organ Procurement Foundation (SEOPF) is an 
example of a voluntary organization of forty transplant centers. The Foundation 
has created a computer network to facilitate organ exchange between 140 trans- 
plant programs, listing approximately 5,500 prospective renal transplant recip- 
ients. Through the membership's tissue typing laboratories, uniform techniques 
generate information that allows priority distribution of organs to individuals 
who are most likely to benefit from the advantages of histocompatibility 
matching. The efforts of the membership have resulted in advances in organ 
procurement and preservation, professional and public education, and scientific 
information. The technology is adaptable to other organs. 



23-029 0-83-12 



174 



Mr. Chairman and members of the committee, I am William W. Pfaff, M.D. of 
Gainesville, Florida. I am a professor of surgery at the University of Florida, 
Director of the Kidney Transplantation Program. I am the immediate past 
President of the Southeastern Organ Procurement Foundation (SEOPF) and am a 
member of the Board of Directors of that organization. I have been asked to 
describe existing organ sharing, specifically as practiced in SEOPF. 

Under the leadership of David Hume and Bernard Amos, SEOPF was founded in 
1968 by several transplant programs that were predominately mid-Atlantic in 
location, to explore the feasibility and effectiveness of organ sharing to: 

a. Verify the worth of tissue typing to improve graft survival in the 
general transplant population. 

b. Provide an opportunity for transplantation for individuals who 
required a well-matched graft. 

c. Aid in the development of organ preservation. 

d. Foster effective use of kidneys when a recipient was not available 
locally. 

e. Develop uniformity of tissue typing techniques. 

There has been growth of SEOPF over the ensuing fifteen years. There are 
now forty members embracing an area that extends from New Jersey to Indiana to 
Louisiana to Florida. The membership performs 1,200 cadaver transplants per 
year, approximately one-third of the national activity and serves approximately 
one-third of the dialysis population suffering from end stage renal disease 

(ESRD). 

With maturation of the organization, the original efforts hava become more 
intense and our purposes are broadened. 



175 



TISSUE TYPING 

During the past decade, tissue typing has become ever more complex. There 
are new antigen systems, which are surface markers on cells, that allow identi- 
fication of similarities between a potential donor and recipient. Successful 
organ exchange depends on the capacity to identify these antigens with equal 
facility in exchanging institutions. Participating member laboratories must 
mature in their capability at an equal pace with trend-setting institutions. 
SEOPF has initiated peer review amongst its members by on-site workshops, mailed 
cell exchanges that allow grading of results to ensure uniformity, inspections 
of laboratories that have undergone change in personnel or that have suspected 
deficiencies in performance. 
ORGAN MATCHING 

As the Organization and the pool of prospective recipients grew, automated - 
identification of the most appropriate recipient became necessary. In an 
evolutionary fashion, computer programs have been refined to allow participating 
institutions to identify all prospective recipients for a particular kidney. 
The putative recipients are categorized by shared antigens listed in order of 
greater to least. 

Prospective recipients are identified by name, age, blood tissue typing 
data, antibody status, duration on the computer list, location of the recipient 
center and telephone numbers for contacting the responsible institution. 

By general agreement, the first priority for sharing is a perfect tissue 
typing match. At" lesser grades of sharing, other factors assume priority, 
including distance, multiple candidates in one center and additional immunologic 
factors. 

Unless delegated, as will be discussed further, the donor center maintains 



176 



responsibility for selecting a prospective recipient center and transporting the 
organ thereto. 
CROSS MATCHING 

One barrier to a successful transplant or the culmination of an intended 
sharing is the occurrence of antibodies, proteins that are capable of injuring 
foreign antigens. As a result of blood transfusions, pregnancy, or prior 
transplants, a patient may generate antibodies that are capable of killing the 
cells of other individuals. Of patients now listed in the computer, forty-six 
percent have antibodies directed against greater than sixty percent of the 
general population; twenty-seven percent have antibodies against an excess of 
ninety percent of the population. 

For economy of dollars, time, and most important, the successful use of 
organs, it is important to be able to predict whether the serum of a recipient 
at a distant center will or will not kill the cells of a donor. If so, this is 
a positive cross match and that recipient is eliminated for the same effect will 
be wrought on the kidney or other organ. 

In SEOPF, we particularly circumvent this problem by sharing serum of pro- 
spective recipients who have highly reactive antibody so that the donor center 
has cross matching material at hand. In consequence the donor center performs 
preliminary cross matches on all prospective recipients in whom antibody might 
present a problem. 

When sharing an organ with non-members, there is a greater possibility that 
a positive cross match will ensue. It would be desirable if the system described 
above or some other alternative could be adopted for inter-regional sharing. 
ORGAN PROCUREMENT 

All members of SEOPF assume a responsibility for organ procurement. The 



898 




111 


31% 


250 


28% 


209 


23% 


90 


10% 


72 


8% 



177 



statistics for7/l/82 - 12/31/82 are expressed as follows: 

Total cadaver kidneys procured 

Kidneys used in local center 

Kidneys shared in SEOPF 

Kidneys shared outside SEOPF 

Kidneys not used (local decision) 

Kidneys not used after sharing 
In the same six-month period: 

New SEOPF patients registered on computer 

SEOPF patients transplanted 

Kidneys from local sources 

Kidneys from SEOPF 

Kidneys from outside SEOPF 
These data provide an overview of the relative success of organ procurement 
in SEOPF. Pertinent conclusions are that: a) Kidney procurement in the region 
outstrips transplantation; b) SEOPF is a net exporter of kidneys, providing more 
kidneys to non-members that receiving same; c) two-thirds of kidneys obtained in 
SEOPF are being shared; d) the discard rate of unshared kidneys is probably 
acceptable. (Note: Kidneys are discarded for a variety of reasons, including 
anatomic or functional abnormalities, systemic findings in the donor, or failure 
to identify an appropriate recipient.) 

The rate of organ procurement has steadily grown, and the ratio of 
transplants to nev patients has decreased. 
SCIENTIFIC ACTIVITIES 

In the mid-70' s, it was recognized that our combined efforts could poten- 
tially answer many of the vexing questions that were raised by the varied 



689 




604 




277 


46% 


250 


41% 


77 


13% 



178 



processes and circumstances that attend the complex steps that are involved in 
organ transplantation. These included patient survival statistics, graft 
success, differing drug protocols, transfusion policies, means of organ preserva- 
tion, import of tissue typing characteristics in different patients. In the 
absence of a national information registry, this pooled information has become 
an important resource for understanding the changes that are occurring in 
transplantation success and to allow comparison of individual programs with a 
broader experience. Multivariant analysis has been applied to gauge a variety 
of risk factors, so that one might modify the circumstances under which one 
might proceed with a transplant. A number of important reports have added 
assistance in answering our constant queries as to the effect of variables in 
patient selection and management. 

Parenthetically the data bank is currently limited to transplant patients, 
lacking information on the majority of ESRD patients who are managed by 
dialysis. At present, comparative data is available only through the ESRD 
networks. In my own state of Florida, I depend on the Network 19 data to help 
make the judgment as to the relative risks of various modes of dialysis and 
transplantation, including information as to the major risk factors. I thus 
strongly applaud the efforts of those members of the House of Representatives 
who favor continued and augmented funding for the Networks. The information 
derived has fiscal and rehabilitative import. 
INNOVATIONS 

In 1977, the technology of computer exchange was made available to SEOPF 
non-members by creation of an entity known as UNOS, the United Network for Organ 
Sharing. The cost is limited to the purchase of a terminal, direct charges for 
telephone and computer time, and a minimum fee for the accountable 



179 



administrative expenses to maintain this service. Currently 100 UNOS programs 
list approximately 3,000 prospective recipients so that the combined UNOS-SEOPF 
listing includes 140 programs and 5,500 patients. Organ exchange can thereby be 
facilitated amongst UNOS members as well as between SEOPF and UNOS members. 

A more recent experiment was the establishment of a 24-hour staff at SEOPF 
headquarters in Richmond, Virginia. The aim was to use these individuals to 
make the many phone calls that are often involved in the placement of a shared 
kidney, to arrange transportation, tying in with commercial airline computer 
services, to take advantage of charter flights that are underway to reduce 
transportation, and to free local personnel to pursue their many other tasks in 
organ procurement and professional and public education. This project was 
established as the result of a grant by the American Kidney Fund and 
continuation will be determined by the SEOPF Board of Directors in one month. 
EDUCATION 

The Foundation has been heavily involved in education of peers in 
transplantation, fellow professionals, our patients and the public. Manuals for 
tissue typing, organ procurement and organ preservation are regularly edited as 
innovations lead to improved techniques. We have undertaken dialogues with 
neurologic and neurosurgical colleagues to urge their cooperation, with critical 
care nurses and physicians. Ultimately we are dependent on the public's 
understanding. My own bias is that too little has been done and invested in 
this specific area. 
GOVERNANCE OF SEOPF 

Membership in SEOPF is voluntary and is institutional. Each participating 
transplant center names a director who has equal voice with all others at 
triannual meetings. An Executive Committee operates in the interval, their 



180 



decisions affirmed by the full Board. 

The day-to-day business of the Foundation is conducted by a salaried 
Executive Director and his staff. 

The many tasks are initiated by committees addressing various distinct 
areas, that is tissue typing, education, procurement, et cetera. Participants 
include all disciplines involved in procurement, exchange and sharing — histo- 
compability technicians, nurses, coordinators, hospital adminsitrators , 
nephrologists , immunologists and transplant surgeons. 
COSTS OF SEOPF 

The current expenditure for maintenance of the Organization, expressed as 
cost per shared kidney follows: 

General and Administrative costs $243.91 
Computer Network 167.53 

Education 128.88 

$540.32 

The current average cost of obtaining a kidney for transplantation is 
$7,729.00. This includes some of the expenses of evaluating patients for 
transplantation. The average cost of transporting shared kidneys is $392.00. 
SEOPF cost currently forms 6.2% of the total expense. 
ASSESSMENT 
1. Is this an effective system? 

My program sought and has continued membership in the belief and now the 
conviction that membership would enhance our performance. This subjective 
conclusion is buttressed by ongoing improvement in graft survival in my own and 
other programs. While all of this is not directly attributable to membership, 
many of the innovations and certainly the emphasis on organ sharing has been a 



181 



product of our membership. 

2. Might these and similar approaches be used in other regions? 

Many areas have sharing agreements and varied cooperation in other 
activities. The evolutionary broadening of the activities of SEOPF would seem 
to have merit to us, yet most of us do not feel that SEOPF as such could exist 
as a national organization because of cost and the loss of the extensive 
communications we maintain between institutions to complete our tasks. There 
would seem to be advantages to regional organization with inter-regional 
cooperation. 

3. Can the techniques used in kidney sharing be applied to other vital organs? 
The criteria for determining priority will differ and needs to be resolved 

by centers transplanting the heart, liver or pancreas. As the number of 
donating and transplanting centers grow, and as the potential recipient 
population swells, it would seem natural to take advantage of the computer 
network and the tissue typing laboratories that currently provide these 
services. SEOPF has recently initiated a formal extra-renal computer program, 
the cost and charge segregated from the kidney program because of Medicare 
considerations . 

4. Is there increasing success in transplantation? 

Not considering the potential for improved graft survival as a result of 
new immunosuppressive agents, SEOPF and Florida Network data both show 
substantial improvement in transplant function and decline in patient mortality. 
The Florida data comparing dialysis and transplantation in the most scrupulous 
and controlled fashion, shows no difference in the risk of dialysis and 
transplantation, and with broader considerations, shows advantage to trans- 
plantations in young individuals. The clear advantage of transplantation lies 



182 



in reducing morbidity, returning people to productive lives, and reducing the 
annual expenditures for end stage renal disease. 

5. If the rate of transplantation should increase, can sufficient organs be 
obtained to meet needs? 

The success of organ procurement efforts varies widely, and probably 
reflects the investment of time and personnel by transplant programs and 
voluntary agencies. Within SEOPF, more organs are being procured that are being 
transplanted by the membership. Isolating by subregions, those states that are 
effective in organ procurement demonstrate that within a broad population base 
there is sufficient organ availability to allow expansion of transplantation. 
It follows that similar effort by all programs would result in far more organs 
than are available now. 

In addition to local efforts, I would hop that a centralized program using 
national media could be repeatedly addressed to the lay public to educate as to 
the feasibility and desirability of organ transplantation. 



183 



South-Eastern 
Organ Procurement 
Foundation 








184 



T 



ransplantation: 

more than a surgical procedure 



Organ transplantation has been 
one of the most dramatic medical 
achievements of this century. The success 
of transplantation has been brought 
about by advances in surgery, immunol- 
ogy, biochemistry, pharmacology, and 
bioengineering. No longer an experi- 
mental technique, transplantation is 
now the accepted form of therapy for 
many patients with irreversible loss of 
function of many of the body's vital 
organs and tissues. 

Just as transplantation requires the 
cooperation of many disciplines within 



the hospital, transplantation is depen- 
dent upon the cooperation of many hos- 
pitals across an ever-increasing geo- 
graphic area. 

With over 60,000 kidneys trans- 
planted worldwide, a firm foundation 
has been laid upon which transplanta- 
tion can grow. 

A vital force in this growth is. the 
South-Eastern Organ Procurement Foun- 
dation, a unique collection of physicians, 
physician's assistants, surgeons, nurses, 
technicians, and administrators. 




185 



i man sharing and more 



01 
The South-Eastern Organ 

Procurement Foundation 
(SEOPF) was founded in 1969 to coordi- 
nate the organ sharing activities among 9 
medical centers in a 4-state area from Bal- 
timore to Atlanta Today, SEOPF is the 
nation's largest organ sharing program — 
a cooperative of approximately 40 medi- 
cal centers covering nearly the entire 
eastern half of the United States 

The Foundation, a non-profit corpo- 
ration, is owned by its member institu- 
tions, each of which appoints a trustee to 
serve on the Board of Directors. 



The primary goal of the Foundation 
is to increase the quality and quantity of 
organs recovered, to meet the present 
and future needs of the transplanting 
community. In this effort, SEOPF works 
closely with government agencies, indus- 
try, and public and private organizations. 




186 



F 



oundation activities 



Standing committees of SEOPF recommend policies for Bos 
in the following areas: 



Standardization and 
Quality Control 

If organ sharing between centers is 
to succeed, there must be assurances that 
all members are equally capable of pro- 
curing, preserving, tissue typing, and 
transporting organs. Each cooperating 
institution must be certified in these areas 
prior to membership. High standards are 
maintained by annual workshops, con- 
tinuous monitoring, and by the sharing 
of information and expertise. 

Members work cooperatively to 
develop new, more efficient and cost 
effective procedures in all areas of organ 
procurement, recipient selection and 
transportation. 

Meetings are held three times a year 
at different member institutions so that 
members can become more familiar with 
each institution's facilities and personnel. 
These meetings are open to all interested 
persons. 



The UNITED NETWORK 
for ORGAN SHARING 

SEOPF has been a pioneer in the 
development and implementation of 
computerized programs for the registra- 
tion of potential organ recipients and 
donor-recipient matching. 

Each SEOPF member has a terminal 
which links it to the central computer 
housed at SEOPF's headquarters. This ter- 
minal can be used to update the RECIPI- 
ENT REGISTRY at any time. Whenever a 
kidney becomes available, donor infor- 
mation is entered into the computer 
where the MATCH PROGRAM searches 
for suitable recipients, utilizing such fac- 
tors as histocompatibility, patients' medi- 
cal status, and geographic distribution of 
recipients. 

In 1976, at the request of several 
non-SEOPF members, the Foundation 
released this computerized program for 
use by any transplant center wishing to 
utilize its services. The result was the crea- 
tion of the United Network for Organ 
Sharing (UNOS). Today, UNOS serves as 
the registry and matching program for 
nearly the entire United States, with a 
recipient pool of over 5,000 patients. 




187 



rd approval and adoption. The committees oversee activities 



The Kidney Center 

One half of all kidneys transplanted 
in the United States are shared between 
centers locally, regionally, and interre- 
gionally 

In July 1982, SEOPF created the Kid- 
ney Center. The goals of the Kidney Cen- 
ter are to: 

• decrease the cost of transporting 
shared kidneys, 

• decrease the discard rate of shared 
kidneys, 

• increase the utilization of shared 
kidneys. 

With headguarters in Richmond, Vir- 
ginia, the Kidney Center is manned 24 
hours a day, every day, to help transplant 
centers arrange for the most time effec- 
tive and cost effective means of trans- 
porting kidneys. 

Utilizing the in-house computer sys- 
tem, the Kidney Center personnel can 
provide local transplant centers with 
backup and assist in the placement of 
organs. 




Education 

One of SEOPF's major roles has been 
in the area of education. The Foundation 
educates its members through an ongo- 
ing program of seminars and workshops. 
The Foundation also uses its pooled 
financial resources and expertise to cre- 
ate educational materials for the public, 
the professional community, and the 
transplant patient. 

Each year SEOPF produces booklets, 
manuals, exhibits, radio, television and 
print advertising, films, and other audio- 
visual materials to increase awareness 
and understanding of organ donation 
and transplantation. SEOPF-developed 
media is currently being used by trans- 
plant programs throughout the United 
States and abroad. 










188 






ffou 



oundation activities 



Data Collection and Analysis Fiscal Management 



SEOPF's computerized system has 
provided its members with a powerful 
data base for retrospective and prospec- 
tive studies of many factors which affect 
transplantation. This data base includes 
extensive information on all kidneys pro- 
cured since 1977. Information derived 
from these studies is shared with the medi- 
cal community through many papers pub- 
lished in leading scientific journals. The 
data is also used to improve the computer 
system, evaluate procedures, and recently, 
to develop predictive models for aiding in 
the selection of recipients. 



In 1973 the federal government ex- 
tended Medicare coverage to nearly all 
patients with End-Stage-Renal Disease to 
include the costs for dialysis and trans- 
plantation. Under the program, institu- 
tions procuring kidneys can be reim- 
bursed for costs associated with the 
recovery process. SEOPF administers all 
billing for kidney acquisition charges 
when kidneys are shared by its members 
within or outside the SEOPF network. 



HACK ROW 

iONEVS PBOCUF 










UlRF&fi I 




189 



South-Eastern 
Organ Procurement 
Foundation 
Member Institutions 



Alabama 

University of Alabama Medical Center, 

Birmingham 
District of Columbia 
Georgetown University Hospital, 

Washington 
George Washington University Medical 

Center, Washington 
Howard University, Washington 
Army-Navy Transplant Service/Walter 

Reed Army Medical Center, 

Washington 
Washington Hospital Center, 

Washington 
Florida 

Florida Hospital, Orlando 
University of Miami School of Medicine/ 

Miami Veterans Administration 

Hospital, Miami 
University of Florida College of 

Medicine, Gainesville 
University of South Florida/Tampa 

General Hospital, Tampa 
Georgia 
Atlanta Regional Nephrology Center/ 

Grady Memorial Hospital, Atlanta 
Medical College of Georgia, Augusta 
Indiana 
Indiana University Medical Center, 

Indianapolis 
Methodist Hospital, Indianapolis 
Kentucky 

Jewish Hospital, Louisville 
University of Kentucky, Lexington 
Louisiana 

Louisiana State University, Shreveport 
Tulane Medical Center, New Orleans 
Maryland 

Baltimore City Hospital, Baltimore 
The Johns Hopkins Hospital, Baltimore 
University of Maryland Hospital, 

Baltimore 



Mississippi 

University of Mississippi Medical Center, 

Jackson 
New Jersey 
Newark Beth Israel Medical Center/New 

Jersey College of Medicine and 

Dentistry, Newark 
Our Lady of Lourdes Hospital, Camden 
Saint Barnabas Medical Center, 

Livingston 
North Carolina 
Bowman Gray School of Medicine, 

Winston-Salem 
Charlotte Memorial Hospital and 

Medical Center, Charlotte 
Duke University Medical Center, 

Durham 
The North Carolina Memorial Hospital, 

Chapel Hill 
Ohio 
University of Cincinnati Medical Center, 

Cincinnati 
Pennsylvania 

University of Pittsburgh, Pittsburgh 
Puerto Rico 
San Juan Veterans Administration 

Hospital, San Juan 
South Carolina 
Medical University of South Carolina, 

Charleston 
Tennessee 

University of Tennessee, Memphis 
Vanderbilt University/Nashville 

Veterans Administration Hospital, 

Nashville 
Virginia 
Medical Center Hospital/Eastern 

Virginia Medical School, Norfolk 
University of Virginia Medical Center, 

Charlottesville 
Virginia Commonwealth University, 

Medical College of Virginia/McGuire 

Veterans Administration Hospital, 

Richmond 



23-029 o 



83 



13 



190 

Mr. Gore. Congresswoman Schneider, would you introduce our 
final witness? 

Mrs. Schneider. I am more than happy to introduce Mr. Cole- 
man, who is a constituent of mine, and I must say that I am very 
honored to introduce him to us today because he will tell us the 
true-life story of what was involved in having his best friend expe- 
rience — have his child experience the need for a liver transplant 
and how he with a very cool, calm head reacted in a time of crisis. 

I think this probably comes from his training as a policeman; 
how he organized as a citizen activist the solution toward solving 
this problem. 

As I mentioned a little earlier today, because of his efforts and 
the efforts of many others, Justine Pinheiro is currently being op- 
erated on in Pittsburgh, and that is who Dr. Starzl was operating 
on last night. 

So as we sit here we are hopeful that her condition will be on the 
upswing. 

I might also mention that Justine's mother was most anxious to 
appear here today, but fortunately she is with her daughter. Also, 
there is in the audience a member of the board of directors for the 
Donor Alert Program that Mr. Coleman founded. His name is Al 
Skorupa. 

I am delighted to have Mr. Coleman here today to tell us his 
story of frustration and success. Thank you. 

Mr. Coleman. It was really short notice for me, as you probably 
know, and then with Monday, Justine getting notified— you will 
have to excuse my written testimony. I would like to read this to 
you. 

My name is Raymond Coleman. I am a welding supervisor for 
General Dynamics, Electric Boat Division, and founding president 
of Donor Alert, Inc., a nonprofit organization founded in December 
1982. 

I became involved in organ procurement out of a desire to help a 
friend, Jose Pinheiro, whose daughter, Justine, hopefully not any- 
more, suffers from biliary atresia. This friend had been led to be- 
lieve that if he made the public aware of his problem, he might in- 
crease his daughter's chances of getting a liver. 

When he and I became frustrated in our efforts, I went to Mr. 
William Bennett, my general manager, for assistance. I felt that 
being a large corporation and dealing with the media they would 
know better than I how to approach the problem. 

Not only did they lend their expertise to the problem of aware- 
ness, they agreed to pay for Justine's operation. Members of their 
staff worked tirelessly with me asking for no recognition and were 
happy with the thought that through their efforts they may help 
save lives. 

This is the same reason that I am involved. All my efforts have 
been voluntary. I and the others involved receive no pay and have 
nothing to gain by my speaking here. 

Our thoughts in starting Donor Alert were that if we went on a 
national scale by public awareness and education and establishing 



191 

an 800 telephone number, and by using Justine and a representa- 
tive of all people in need of transplant surgery, it would be possible 
to locate enough organs to reduce the waiting list, thus insuring 
Justine s survival and continuing the donor process. 

Being an ex-policeman and having been involved in situations 
that met the criteria of potential donors, we decided to start our 
campaign with police departments. The criteria of being brain dead 
and on life support was not a normal condition of dying and the 
fact that auto accidents, violent crimes, child abuse and drug abuse 
was a major cause of this condition, made us believe that the police 
could be a big help. 

We sent out on a national teletype a message that if they were 
involved in these situations, to please notify the hotline and we 
would notify local donor coordinators. Simultaneously with this 
message, ABC World News Tonight televised our efforts on nation- 
al TV. 

moi nCe the ince P tion of Donor Alert's 800 hot line on January 13, 
1983, we have received over a thousand calls, have established 
chapters in six States, have registered hundreds of donors and have 
come to realize that besides the basic complexities of the area of 
procurement, it is frought with problems. 

Some of the problems we as layman have encountered include: 
first, on the whole, the general public knows nothing of what is in- 
volved in organ transplants, what is necessary to become an organ 
donor, or how to become one, or what to do if they want to donate 
organs. 

Second, although the entire organ donor procurement recipient 
transplant system is run, directed and controlled by medical profes- 
sionals, and for the most part it should be, I have been told I have 
no right or business to be involved in organ procurement because 
we are layman. 

Coordinators have advised me that there is such a delicate bal- 
ance between them and the medical profession that a "bumbling, 
unprofessional might spoil" what they have achieved. 

Our thoughts as bumbling unprofessionals is that if, instead of 
the almost secretive way they approached us, that they educate the 
people, that transplants affect most of the laymen. This way the 
medical aspects would not be a problem. 

If a doctor was told by his patients that they accepted it and 
wished to be a donor, then if the opportunity to be a donor arose, 
the doctor, as a normal part of handling the situation, would offer 
this life-saving option to the next of kin. 

This is not entirely the coordinator's fault. I have been told of 
cases of coordinators being called vultures and chased out of hospi- 
tal rooms for their efforts. They have been accused of preying on 
the dead. J & 

This exists probably because a doctor feels that his first duty is 
to his patient. With proper education of the public and the medical 
profession, it is hoped that once a person reaches a state of being 
legally brain dead, then again, as a normal consideration, a doctor 
would suggest or discuss the options and possibilities of lifesaving 
organ donations. 

As you are aware, it appears that every State, in some cases, 
counties, cities, and regional areas, have organizations, some 



192 

public, some private, some sponsored, involved in some sort of 
organ procurement. 

These people work so hard in setting up their areas in different 
parts of procurement, such as eyes, kidneys, hearts and livers, that 
they feel it is their domain and seem to protect it with a vengence. 

This not only occurs because of territorial protection, but ex- 
treme examples have been related to me of organs that have not 
been routed to an area because of personal conflicts. 

When cur national hot line was set up, it was in the hopes of 
coordinating these efforts. Professional or unprofessional, without 
the layman there would be no organs. With the tremendous ad- 
vance in the medical procedures used in organ transplants and 
with the fantastic success that has been attained in liver trans- 
plants, I think that the time has come for a national computer net- 
work to be established which lists all patients awaiting transplants. 

If this could be accomplished, then when a donor was located, the 
information could be fed into the computer and a match done 
making the selection impersonal and guaranteeing the most criti- 
cal and best match would receive the organ. 

This would make the information available to all medical person- 
nel on a national basis. This should enhance the availabilitiy of 
organs and success rate even more. 

If this is not done in an impartial manner, it could take years for 
all separate factions in organ procurement to become cohesive. 

I have yet to talk to anyone involved in organ procurement who 
doesn't speak of his area in a protective way, and rightly so, be- 
cause of the hard work necessary to develop it, but this attitude 
has to be shed now that organ transplants are growing at such a 
rapid rate. 

Among the first calls we received on the hot line were people 
from NATCO and SEOPF. They stated that this was something 
that should have been done years ago. 

NATCO stated that they would like to work with us on the hot 
line and invited us to Richmond, Va., to meet with members of 
their board. The discussions we had further strengthened my belief 
that a neutral party is needed if a national computer network was 
to be set up. 

There is no room for any conflict when a human life is involved. 
One subject that all parties agreed on was that national programs 
of public awareness and education were necessary and the time 
had passed when they should have been implemented. 

Following the establishment of our national hot line, several 
other organizations have established them. It was felt that a lot of 
money would be needed to accomplish this, so it would be some- 
thing to work on in the future. 

We felt that it could be accomplished now and we proved it. 
Granted, to be as effective as we should be, we still need funding, 
but if the Government never gave us a penny, we would still con- 
tinue to grow because we are driven by a desire to help these beau- 
tiful children and will not be stopped by any obstacle. 

If there is Federal money available, the Government should get 
behind an educational program that has already been established 
rather than putting money into duplicating the efforts of caring 
people who volunteer their time in an effort to help. 



193 

It is my understanding in some areas of transplant there is still 
a shortage of organs, but in liver transplants there are more 
organs than doctors to perform the surgery. Statistics show that 
the success rate in liver transplants has passed the trial and error 
stage and should be classified as a therapeutic and lifesaving proce- 
dure. 

Without Government approval of this operation, hospitals and 
surgeons will not become involved and everyone's efforts will be in 
vain. 

My final statement to you is our experience has shown that once 
people are made aware, they are willing to donate their organs in 
order that others may live. In our short existence we have acquired 
hundreds, approaching a thousand signed donor cards. 

This has come about through what little exposure we were able 
to get. The next and probably greatest problem that exists with all 
cards and donors is that upon death, rarely is anyone sure of who 
they should call and, further, rarely does anyone check for donor 
cards. 

A number of people who signed our donor cards were already 
carrying some sort of a local card, whether it was for kidneys, eyes, 
hearts, lungs or livers. 

These people stated that they felt our national education efforts 
would enhance the chance of the card being looked for and an 800 
number to call would enhance the availability of organs. 

At one of our functions— a story was related to me of a woman's 
mother who before she died expressed a desire to donate her eyes 
so that another might see. Because no one knew who to call, the 
eyes were never donated. 

Stories like this have been told to me time after time. It isn't just 
the man in the street who doesn't know what to do, this also 
extend to some doctors in hospitals. For example, on March 3, we 
received a call from a hospital in Colorado with a potential donor. 

Luckily, they were aware of our 800 number and contacted us. 
We notified a donor coordinator, the liver was matched with a 
child in California. 

What is needed is not 800 different 800 numbers, but 1 central 
800 number that everyone is aware of and able to call for educa- 
tl0 r?i?- information or to either register as a donor or donate. 

This would not infringe on the medical aspects of transplant or 
local and regional efforts, as a local coordinator would immediately 
be notified. 

This concludes my remarks. 

„J r ' G ? RE - Now, let me get this straight. We have two different 
800 numbers. Is that correct? 

Mr. Denny. The 800 number established by the North American 
Transplant Coordinators Organization, 800-24-DONOR, has been 
established for the specific purpose, Chairman Gore, of providing 
information and referral services to physicians and nurses within 
the country. 

It is staffed 24 hours a day by trained organ procurement profes- 
sionals who are totally familiar with the identity of doners, the 
management of donor organ function, the psychological aspect of 
organ donation, the surgical recovery of the organs, and the net- 
work of regional programs throughout this Nation. 



194 

This 800 number, we hope, if made available to the physicians 
and nurses in the country, will enhance the opportunity for the re- 
covery of organs. 

We don't seek to compete with any other organization. We seek, 
however, to exercise our competence in terms of providing the 
health care professionals with the information that they need. 

Mrs. Schneider. Would the chairman yield a moment? 

Mr. Gore. Yes; delighted. 

Mrs. Schneider. Is there any particular criteria — you refer to 
organ transplant professionals, is there some specific type of train- 
ing or criteria that is followed in order to be acknowledged as a 
transplant professional? 

Mr. Denny. When I say transplant professionals, that is a gener- 
ic term meaning the physicians, the surgeons, the transplant, or 
organ procurement coordinators. I think you refer especially to the 
organ procurement coordinators. 

Mrs. Schneider. Yes. 

Mr. Denny. Those of us like myself who operate organ procure- 
ment programs and are available to do all of the necessary work in 
evaluating the donors and making the process work. 

Mrs. Schneider. What I am trying to get at is whether or not we 
can see a new area of professionalism. 

Mr. Denny. There is a new area of competence 

Mrs. Schneider. Is there a recognized curriculum that one would 
take in going to school or the university or postgraduate studies? 

Mr. Denny. No; most organ procurement coordinators are either 
nurses or physician's assistants. Some of us are neither. Some of us 
have no background in medicine. 

Mrs. Schneider. But are you certified? Is there a certification 
program? 

Mr. Denny. There is not yet a certification program, though I 
am sure that we will be moving in that direction. The North 
American Transplant Coordinators Organization does provide an 
intensive, annual educational program for organ procurement coor- 
dinators at the 110 programs in this country. 

Mrs. Schneider. Thank you, Mr. Chairman. 

Mr. Gore. Then, what differentiates you from Mr. Coleman is 
your experience at it? 

Mr. Denny. Knowledge, experience, and the fact that we are in 
the hospitals, that we are involved with the donors in the intensive 
care units, that we sit down and approach the grieving families to 
offer them the opportunity for life. His effort is, I think, primarily, 
and appropriately primarily designed to educate the public. 

I have no quarrel with that at all. I think that it can be a valua- 
ble service. 

Mr. Gore. Well, Mr. Coleman, you see it a little bit differently, 
don't you? 

Mr. Coleman. First of all, I am not here to compete with the 
medical aspects of it. I bow to his expertise, as far as that is con- 
cerned. 

My opinion is that my line can be just as — we both — I think both 
lines are needed. OK? 

That he has done it this way, I don't think was very — how can I 
say it? — fair. If he would have let me know, I would have worked 



195 

with him to make two different lines, one for general information 
and one for medical. 

I would have referred all my calls. I have 35 calls on my desk of 
doctors, nurses, emergency room personnel that want to know 
what to do. If I knew that this was what they were doing, I would 
have just given them his 800 number and done it that way. 

I think that there is room for both in this field. The general 
public needs, I think, the general public to tell it because they 
don t understand sometimes. 

If somebody came up to me and said, will you donate your kid- 
neys, I would say, no, I probably wouldn't. Right? But if somebody 
showed me why it was necessary, and if somebody showed me why 
it was necessary to donate my liver, then I sure would. 

I carry a donor card, and I have been close to it, and I think if 
you put it to the people that way, people would understand and 
they would donate their organs, and there wouldn't be some of the 
problems that we have today. 

xt ?fc, J-£ NNY - Ma y l mention something with regard to the 
NATCO 24-DONOR number? 

Let me describe to you something in a hypothetical situation 
something of how the process works. A patient— this will be brief— 
a patient involved in an automobile accident, strikes his head 
against the windshield. 

He is brought into the hospital. He is bleeding profusely. His 
blood pressure is dropping down to the danger level where his 
heart function is compromised. 

His oxygenation is impaired because his breathing is slowing 
down. He needs to be put on a ventilator to support the oxygen- 
ation of his blood, to sustain the viability of the organs. 

A doctor recognizes this patient as a probable victim of brain 
death He is moving in that direction rapidly. It is a question of 
should the family be asked, should the family be approached, 
should they be offered the chance to think about donation? 
u u n u eds to talk witn someb <>dy immediately. Not only about 
should he talk with the family at that point, he needs to talk with 
somebody rapidly about what to do to sustain the vital organ func- 
tion. 

In dealing with victims of brain death, there are a number of 
physiological problems that occur that are not common to those of 
us who are living. Maintaining the organ function in somebody 
who is a victim of brain death is always a race against the clock. 

It is always a competition between nature and those of us in 
transplantation whether or not the organs will be recovered in 
time. A physician who calls an 800 number needs to talk to a pro- 
fessional immediately who knows what to do to stabilize the blood 
pressure, to maintain the oxygenation, to assess when and how to 
talk with the family, to determine who is a suitable prospective 
donor. 

r»™™ eeds [t ra P idl y- The fact that our 800 number, 800-24- 
DONOR, is manned by trained procurement professionals, is a vital 
service to the physicians and nurses in this country. 

Mr. Gore. Well, I think I see the two points of view represented 
here. You just think that Mr. Coleman's group is not qualified to 
perform the function that you wish to perform. 



196 

Mr. Denny. Mr. Coleman and I have spoken over the phone 
about this on a number of occasions, and we had breakfast this 
morning together. 

We concur in having the same shared sense of urgency. We 
concur in the sad realization that few of the available organs are, 
in fact, recovered. 

Our concern, the professional organ procurement coordinator's 
concern is that the professionals be educated — I think Mr. Cole- 
man's primary concern is that the Nation be educated, the public 
be educated. 

Mr. Gore. And he faults the professionals for failing to do that. 

Mr. Denny. Perhaps not without some justification. I think that 
we can do a better job. It is a question of money. I have 95 hospi- 
tals in a 150-mile radius of Pittsburgh to cover; approximately 
15,000 beds. I don't know how many physicians and nurses. 

Mr. Gore. Now, wait a second. You cover 90 hospitals in 

Mr. Denny. Ninety-five hospitals. 

Mr. Gore. Ninety-five hospitals in a tri-state area around Pitts- 
burgh. 

Mr. Denny. Right. 

Mr. Gore. Now, is there a feeling on the part of somebody in 
Texas, say, that if they plug into your network that is based in 
Pittsburgh, then facilities in Texas are going to be disadvantaged 
and patients in Texas are going to be disadvantaged relative to pa- 
tients in the Pittsburgh area? 

Mr. Denny. No; when I say our area, I mean the geographical 
area in which we are responsible for the education of the doctors 
and nurses surrounding Pittsburgh. 

Mr. Gore. But you wear two hats; right? 

Mr. Denny. The rest of the country is broken up into similar 
geographic areas. We wear the second hat in the sense that we 
share organs with other programs similar to ours. 

Mr. Gore. Aren't some of those people that are wearing two hats 
in the rest of the country skeptical of your national group because 
it is collocated with your regional group? 

Mr. Denny. No, sir, it is not collocated with our regional group. 
It is, in fact, at this time manned by the coordinators at the Uni- 
versity of Pittsburgh. 

Mr. Gore. They are both in Pittsburgh. 

Mr. Denny. This function will be taken over within the coming 6 
months by another group. 

Let me explain, Congressman Gore. No; it is an information and 
referral service. If this hypothetical emergency room physician 
calls 800-24-DONOR, his burning, urgent questions will be an- 
swered, and then he will be immediately put in touch with the 
organ procurement professionals at his regional group. 

If he is in Amarillo, Tex., we will put him in touch with the pro- 
curement people in San Antonio. 

Mr. Gore. Maybe I heard you wrong, didn't you say in your testi- 
mony that there are 110 procurement groups around the country? 

Mr. Denny. Yes, sir. 

Mr. Gore. Didn't you say that only 50 of them will communi- 
cate 



197 

Mr. Denny. No, sir, I alluded to the fact that the University of 
Pittsburgh has worked collaboratively with approximately 50 of 
these organ-procurement programs in recovering livers and hearts 
for transplantations. 

Mr. Gore. I see. So, that was the other half. 

Mr. Denny. We have worked with 50. There are another 60 that 
we have not worked with either because geography or time con- 
staints prevent us from flying to the coast, for instance. 

Mr. Gore. OK. So, you are wearing your local hat when you are 
talking about 50 other regions that you have cooperated with. 

Mr. Denny. Yes, sir. 

Mr. Gore. I see. Now, how many of the 110 procurement systems 
communicate regularly with your national organization, the North 
American 

Mr. Denny. Almost all of them. Almost all of them make use of 
the NATCO 24-Alert System. We have two systems. Don't get them 
confused. 

The 24-Alert System is the recorded phone message system so 
that a procurement coordinator in Amarillo, Tex., can call and find 
out where a patient is who needs an organ from a donor similar to 
the one that is located in Amarillo. OK? 

Mr. Gore. Yes. 

Mr. Denny. That is the 24-Alert System. Almost everybody in 
the country uses that system to find suitable recipients for availa- 
ble, extra-renal organ donors. 

For instance, the University of Arizona transplant team flew to 
El Paso, Tex., over this past weekend and recovered a heart be- 
cause the procurement people in El Paso had called 24-Alert, 
learned that the University of Arizona was looking for a heart 
from a donor similar to the one they had. 

They, in turn, called Arizona, and the two teams got together to 
recover the organs. 

Mr. Gore. Dr. Pfaff, we have talked about these two 800 num- 
bers, the two hotlines, and I understand the difference. Mr. Cole- 
man, would you publicly recommend that a doctor call Mr. Denny's 
hotline and that public citizens interested in information call 
yours? 

Mr. Coleman. Yes; if I had a call from a doctor, I would refer to 
a local coordinator in his area, anyway. 

oJ^\ G ^£ E - That num °e r > again, it is really easy to remember, is 
800-24-DONOR. 

Mr. Coleman, what is your 800 number? 

Mr. Coleman. 800-352-7001. 

Mr. Gore. 800-352-7001; right? 

Mr. Coleman. Yes. 

Mr. Gore. Dr. Pfaff, in addition to there being these two num- 
bers, there are, I understand, two computer registries; is that cor- 
rect? One, the UNOS system, and the registry operated by Dr. Ter- 
asaki s group at UCLA; is that correct? 

Dr. Pfaff. That is correct. 

Mr. Gore. To what extent do these two computer registries over- 
lap? 

Dr. Pfaff. They do overlap. 
Mr. Gore. They do? 



198 

Dr. Pfaff. Yes. UNOS membership and utilization is voluntary. 
All you have to do is buy a display terminal, pay your phone bill 
and pay for computer costs. In effect, it is the extension of the 
SEOPFs approach. 

Mr. Gore. Wait a minute. The SEOPF? 

Dr. Pfaff. South-East Organ Procurement Foundation. We will 
call it southeastern region. The southeastern region's technology 
just expanded nationally. 

Dr. Terasaki has a very large tissue typing laboratory that serves 
almost all of the southern California programs. Much of their work 
is unified in his laboratory or by exchange with other laboratories 
that are generally located in the southwest. 

There is no competition between the two. It can be complemen- 
tary. My principal interest is in seeing the overall activities of our 
region perhaps adopted by other regions locally and then with 
inter-regional cooperation. 

As you mentioned, we have our own 800 number, too. 

Mr. Gore. You do? . 

Dr. Pfaff. I don't know what the number is. Basically it is lor 
people to call in and sign donor cards. I don't think that there is 
any argument about a whole bunch of people doing some things 

that may overlap. . • 

The biggest message we have heard today is that the public does 
not know, some professionals don't know or that they need to be 
reminded over and over again, and so that there is not— it 
shouldn't be thought of as competition. 

I hope that there is a heck of a lot of supplementation. It took 
me a long time to learn how to read. 

Mr. Gore. Unfortunately, it has taken a lot longer than that to 
get the awareness of the importance of organ donation. 

Dr. Pfaff. We are doing a good job. For example, in our region— 
I will tell you, we are outstripping our use. That isn't the total 
matter, though. We are looking forward— and I agree with Mel, 
again, as to what should happen with transplantation. 

I say it should double in terms of kidney transplants. You have 
heard that liver transplantation is going to increase in numbers. 
We are going from a number of roughly a hundred a year to more 
than that. 

Cardiac transplantation is going from a hundred a year to more 
than that, so that we need to be looking towards the future. We 
need to modify our practices that we are using now. That is all. We 
need some help in doing that. I think many of the things that we 
have talked about we can do, the one that I can't do is to make 
sure that we are getting accurate information. You can really help 

us there. 

Mr. Gore. There are, Mr. Denny, 35 children awaiting a liver 
transplant at Pittsburgh right now; is that correct? 

Mr. Denny. Yes. Approximately. 

Mr. Gore. How do you assign a priority as to which one ol those 
children gets a liver that becomes available, assuming that several 
have tissue compatibility and the rest. 

Mr. Denny. Let me explain one thing. In terms ol liver trans- 
plantation, we do not look at tissue compatibility as we do in renal 
transplantation. That is why Mr. Coleman's suggestion that a na- 



199 

tionwide computer system be established so that we could sort out 
suitability for an available liver on the basis of tissue typing is not 
practical. 

Let me answer your question on two levels. 

Mr. Gore. We have to sort it out on the basis of size, don't you? 

Mr. Denny. Size and compatibility of blood type between donor 
and recipient. 

Mr. Gore. I see. Let's suppose that you have several that have 
the same blood type compatibility and size compatibility, how do 
you assign priority? 

Mr. Denny. If a donor is referred to the University of Pittsburgh 
and we have several people who are equally suitable for transplan- 
tation, the decision is left up to the physicians. Dr. Starzl and some 
of his colleagues make the decision based on the urgency of need. 

All of these youngsters are going to die. Some, unhappily, will 
die before others, and they should be given the priority. That, in 
fact, is what is done. 

Occasionally, we have to compromise. Occasionally, we have only 
an hour or two advance notice that a donor is available, and we 
may have a recipient who has an urgent need on the west coast 
2,000 miles away, a slightly less urgent need recipient in Pitts- 
burgh. 

If we have only an hour or two to get that liver, we will have to, 
sometimes, select the less ill child. Generally speaking, all things 
being equal, we will pick the child, Dr. Starzl will pick the child, 
who is most desperately in need. 

In the case of the 24-Alert System, again, the telephone service is 
available to organ procurement people to help them understand 
where there is a need for a liver or a heart that a donor in their 
area might provide. 

On the 24-Alert System, if you call it, you will hear that the Uni- 
versity of Pittsburgh, the University of Tennessee, Massachusetts 
General Hospital, Sacramento, Calif., Davis Medical Center are all 
looking for livers. 

We prioritize the recipients in terms of the urgency of need. In 
other words, at the University of Tennessee for the last several 
days there has been recognized a very urgent need, what we call a 
priority one recipient. 

That was the youngster that we saw this morning. This young- 
ster is identified as a priority one recipient on the 24-Alert System, 
so that a calling coordinator, such as the coordinator in Virginia 
who called last night, is alerted to the fact that this need is per- 
haps more urgent than other needs for liver transplantation among 
children of the same size and blood type elsewhere in the country. 

Mr. Gore. Very good. Let's suppose we could get hospitals to put 
up notice about the 800-24-DONOR number and for public infor- 
mation, your number, Mr. Coleman, that might be helpful, would it 
not? If emergency room physicians and critical care nurses and 
hospital administrators knew about this number, then they 
would—well, maybe it would make them think more often. 

That is, I am sure, the intent of both of you, partly, in establish- 
ing such numbers. 

Dr. Pfaff. Congressman Gore, actually I think that there is an- 
other solution. For example, if somebody from northern Florida 



200 

were to call their number to find out that they should call us and 
get some help, we have done a bad job. So I think that you have got 
to pay heed to — literally hundreds of people are active in organ 
transplantation these days, and they are scouring those hospitals. 
If we aren't scouring them well, we haven't done a good job. 

Have all of our programs done good jobs? No. Some are doing 
great and some aren't doing so great. We need to push ourselves a 
little more, too. 

I should have made that point earlier. I don't think everything 
flows from a single source. Just as I differ with Don regarding 
making a potential recipient list available to donor hospitals in 
hard copy because that list is going to get awful lengthy. 

Mr. Denny. We don't differ on that. 

Mr. Gore. Now, Mr. Denny, financial considerations enter into 
this priority. I guess you don't even get considered for priority typi- 
cally unless the financial threshold has been crossed. 

Mr. Denny. The child has to be accepted for liver transplanta- 
tion at that center providing 

Mr. Gore. The center typically turns down patients that don't 
have the ability to pay unless the mother can do what Mrs. Hall 
did and get a radio station and a lot of friends to help her raise the 
money from volunteer donations, poor people don't have the same 
chance, do they? 

Mr. Denny. It depends on what State the poor people live in. In 
some States medicaid has been helpful for those who are sufficient- 
ly indigent to allow them to qualify for medicaid. 

Mr. Gore. In States where medicaid will not pay, then they are 
out of luck. 

Mr. Denny. Occasionally, families have been forced to turn to 
their communities for help. We have transplanted several patients 
in this group. Families having turned to their communities, having 
found the generosity of the neighbors, have recovered the funds 
through fundraising drives in their own areas and have been trans- 
planted. 

It does require that on occasion, yes. 

Mr. Gore. Mr. Coleman, do you believe that the organ procure- 
ment effort in the country has been impaired by competition be- 
tween different organ procurement systems? 

Mr. Coleman. Yes. I have heard of different situations where 
that has happened. But, basically, I have to say this, they are hard 
working, dedicated people. 

When they started in this, it was almost considered a macabre 
thing. But today people accept it and it is growing so fast that I do 
believe that these personal conflicts or if somebody is mad at some- 
body else or something this, should be removed somehow. 

If it has to be forced upon them, removed. There shouldn't be 
any type of personal conflict in something like this when it in- 
volves a human life. 

Mr. Gore. Mr. Coleman, I was looking at the list of organ pro- 
curement programs provided to us, and I notice that many cities 
around the country have more than one organ procurement system 
in the city, and some have as many as five different organ procure- 
ment systems or networks in the same city. 

How does that work? Does that cause problems? 



/ 



201 

Mr. Coleman. Again, I just go by the personal talks. The medical 
people can tell you more on that. 

Mr. Gore. Dr. Pfaff. 

Dr. Pfaff. Really, no, it shouldn't cause problems. Are they com- 
peting for the same attention? Yes. How did this ever happen? 

Organ procurement is an outgrowth of transplant programs, in 
the main, In some areas, people have seen advantage to coales- 
cence. It is like anything else that a bunch of people do together. 

There has to be not only a mesh of purpose, but very important, 
a mesh of personalities and some personalities don't get along with 
others. 

Mr. Gore. Doesn't it make sense — I mean, if we have a situation 
where we have 110 different systems around the country, as many 
as 5 separate systems in the same city in some cases. We clearly 
see on the horizon a dramatic upsurge in the number of transplant 
procedures being performed and the demand for organs for trans- 
plant. It really makes sense to have a national strategy to, if not 
coalesce them all into a single system, at least devote a sufficient 
amount of attention to get rid of any competition that is impairing 
the procedures and make it a more sensible and rational system. 

Dr. Pfaff. The competition doesn't impair the procedures. As a 
matter of fact, one of the major coalescences was just a dismal fail- 
ure. That really isn't the matter. 

It is really the question of effort, and the attention of a number 
of decisions that each of us make individually in terms of sharing 
organs and increasing production, of transplantation as a whole 
are all really scientific decisions in the end. 

I think if all of us see the need for more organ procurement, we 
will do it. If, as people have heard today, there is a shortage of pe- 
diatric donors for a particular problem, biliary atresia, coordinators 
are going to pay attention to that. 

Physicians are going to pay attention to it. Nurses are going to 
pay attention to it. They are going to hear it on the night news, I 
suppose. 

Mr. Gore. Well, there is clearly a need for more organ procure- 
ment. I mean, there is not any doubt about that, is there? 

Dr. Pfaff. Oh, I think in some areas there is doubt. In some 
areas, in some organs, I mean we are talking about now three liver 
programs in the country, ten cardiac programs. 

Mr. Gore. We have got 35 children at this one hospital alone 
that are going to die if they don't get a liver. They are waiting for 
one now. 

Dr. Pfaff. Thirty-five are waiting? 

Mr. Denny. Yes. 

Dr. Pfaff. Are on the list? 

Mr. Denny. Yes. 

Dr. Pfaff. That represents a very high proportion of probably 
the number of individuals in the country. I think that you need to 
understand that. 

In other words, their need is for us nationally to provide organs 
to them. 

Mr. Gore. Let me conclude 1 second. I am a little unclear about 
this. I am told that there can be expected to be as many as 4,000 



202 

people whose lives might be saved by a liver transplant in this 
country compared with 5,000 kidney transplants annually. 

Mr. Denny. That is a projection based on epidemiological data. 
There are at least two problems in realizing the promise of liver 
transplantation. Certainly the first and foremost is funding, which 
we have heard today, and the second we have also heard today is 
the shortage of available organs. 

Liver transplantation, you have to realize, until 2 years ago had 
results which did not recommend it as a therapy to be frequently 
applied. 

It has only been within the past 2 years that liver transplanta- 
tion has achieved the status that it has achieved. So we are talking 
about the future. 

We are talking about something that is building dramatically. A 
year ago there was only one liver transplant program in the coun- 
try. Then there were two. Then there were three. Now there are 
six. 

By this time next year there will be another six. The number is 

growing rapidly. 

Mr. Gore. Dr. Starzl said that as these regional centers develop 
and more patients are identified and we are able to treat more pa- 
tients, that it would approach the level of 4,000 a year. I mean, 
that is a lot bigger than 35. 

Dr. Pfaff. Yes. 

Mr. Gore. So, clearly, there is a need for 

Dr. Pfaff. If it grows to that point and if that is the need and 
the number of individuals with hepatic failure, clear hepatic fail- 
ure, and that is not just all the hepatic diseases and not all of the 
hepatic diseases that may result in death— I am getting overly 
technical, but if that were to happen, clearly we are going to need 
a good deal more donors, but the same is true for transplantation 
of each of the other organs that you have mentioned. 

Mr. Gore. Thank you for your indulgence, Congresswoman 
Schneider. 

Mrs. Schneider. Of course. You are the chairman, after all. 

I must admit that after listening to the testimony by this partic- 
ular panel, I am not at all convinced that despite the very dedi- 
cated efforts of keeping the public informed and providing a public 
service that it is as effective as it ought to be. 

I guess to express that in more specific terms, I had asked my 
staff person here, Don Rheem, to go to the telephone and call the 
operator for 800 numbers and see what kind of information he 
could find. 

I would like to relate to you the conversation that transpired. He 
called the operator and he said that "I have an organ to donate, 
and I would like the toll-free number, please." 

She said, "May I have the agency name?" He said, "I have no 
agency name." 

She then said, "Well, just a moment, I will give you the supervi- 
sor." 

Well, essentially the supervisor went through the same thing 
and then putting on her thinking cap said, "Well, why don't you 
call your local hospital." 



203 

I am under the impression that if I were to call my local hospital 
now and ask for information on donating a particular organ, I 
would probably get nowhere. 

It seems to me that there is a definite need to pursue the net- 
work of professional communications with the doctors and the 
nurses, but also the need for the public citizen information that 
would very clearly answer general questions such as if I wanted to 
donate my organ, who do I go to, where do I begin? 

One of the things that I am concerned about is the regional as- 
pects of the problem. I would certainly hope that when it is recog- 
nized that we have the interest of some very powerful professional 
groups and organizations, such as the AMA, and the American 
Hospital Association, we can get a great deal of public service work 
accomplished by groups like the American Heart Association, the 
Lung Association, and other citizens' associations that we ought to 
be able to solve this problem. 

Now, my great concern is that, yes, here we are in a congression- 
al hearing and so we always look for solutions that are derived 
from our jurisdiction, but it seems pretty clear to me that there is 
little we can do on this. 

Now, I wonder is there agreement by this panel with me that 
there is nothing that we can specifically do? 

Dr. Pfaff. My statement earlier was we had to do a hell of a lot 
of it. There are a few things you can do. 

You can foster good information getting back to us about current 
success in dialysis and transplantation. That is a responsibility the 
Federal Government assumed and has not fulfilled. 

So that is one thing that you can help us with. 

Mrs. Schneider. Information generation. 

Dr. Pfaff. Information. You must, I think, participate in the ar- 
gument about funding for these other organs. 

Mrs. Schneider. That is the next topic that I would like to dis- 
cuss, is the funding. 

Mr. Denny. Let me mention, again, I think, Congresswoman 
Schneider, that I think the Federal Government can do something 
that you as a Representative and your colleagues can do some- 
thing. 

The fact that medicare now funds 94 percent of the kidney trans- 
plants in this country and is ostensibly very eager to increase the 
number of patients transplanted, argues that medicare administra- 
tively should be in a position to implement c financial incentive 
system for those hospitals which generate donors of kidneys. 

The Health Care Finance Administration is in a position to im- 
plement something like that without any legislative alteration in 
the Social Security Act. 

On the other hand, they are not going to do it unless they get the 
pressure put on them to do it. 

Dr. Pfaff. Are you suggesting a bonus system? 

Mr. Denny. I am suggesting a financial incentive of some kind. 

Mrs. Schneider. Such as a tax credit or a reduction in a medical 
bill? 

Mr Denny. For instance. I leave it to wiser minds than mine. 
But hospitals, you know, are heavily dependent upon medicare. 



204 

Medicare is heavily dependent upon the hospitals for the recovery 
of kidneys for transplantation, which is funded by the Government. 

It only makes sense to me to move in a direction— the heart 
strings of the hospitals are closely tied to the purse strings of the 
hospitals. 

Mr. Gore. Will my colleague yield? 

Mrs. Schneider. Sure. . 

Mr. Gore. I would hope my colleague would wait until the end ot 
the 3-day hearing to make the judgment that there is nothing we 
can do. I think already we have had a number of recommendations 
that could be included in a list of productive actions on the part of 
the Federal Government, not least among them, changing the pro- 
cedures at CHAMPUS that deny approval of the transplant oper- 
ations for children such as Captain Broderick's daughter. 

In addition, I anticipate that we will have a list, a lengthy list ol 
recommendations, many of them involving changes in Federal law, 
none of them as productive as or as important as the effort to in- 
crease the public's awareness of making organs available, but all of 
them helpful and all of them perhaps contributing to that larger 

Mrs. Schneider. Mr. Chairman, my question was specifically ad- 
dressed to the 800 numbers, to the information exchange and the 
two separate networks, and I don't think that there is really any- 
thing that we can do on that score. 

I would like to address the costs of the 800 numbers and the in- 
formation exchanges that you do have. Mr. Denny, can you give us 

We know now the breadth of your communications network. Can 
you give us an idea of the cost of that network? 

Mr. Denny. Again, I have to differentiate between the two tele- 
phone systems that the North American Transplant Coordinators 
Organization has in place. The 24-Alert System, the recording 
system, which is updated two or three times a day to acquaint 
organ procurement professionals with the need for hearts and 
livers is a minimal cost. 

It is not an 800 number. The caller, the organ procurement pro- 
fessional who is in the donor hospital has the burden of paying lor 
that cost. That is not a problem. We all have credit cards. We just 

The cost of setting that up was less than $200. The cost of the 
800 number that NATCO has established, annually will be— it de- 
pends on the times and charges— but we expect that it will run be- 
tween $6,000 and $7,000 a year. 

That is merely for three lines. 

Mrs. Schneider. How about for the people who are operating 
those lines? I mean your overall information network, total cost, is 
about how much? 

Mr. Denny. The indirect cost for the time of the organ procure- 
ment professionals? 

Mr. Denny. I have no handle on that. Again, our system has 
only been in place for 10 days. m 

Mrs. Schneider. That is true. Are volunteers right now manning 

those phones? 



205 

Mr. Denny. No, ma'am. 

Mrs. Schneider. Paid professionals? 

Mr. Denny. Professionals like myself, my colleagues, yes. 

Mrs. Schneider. Mr. Coleman, can you give us an idea of some of 
the costs of your information network? 

Mr. Coleman. The line costs us, again, depending on how much 
time is used, it averages $180 a month. We pay $30 a month for a 
24-hour answering service. The line is manned 24 hours a day. 

We pay $40 a month for an emergency beeper which I carry at 
all times. That is the cost of our line, about $250 a month. 

We started this whole organization with a couple hundred dollars 
and a lot of effort. 

Mrs. Schneider. All right. Terrific. I have no further questions, 
Mr. Chairman. Thank you. 

Mr. Gore. Dr. Pfaff, what effect do you expect the new prospec- 
tive payment reimbursement systems to have on the organization 
and function of organ procurement programs? 

Dr. Pfaff. Gosh, I am not sure what diagnostic category they are 
going to use. There actually is quite a range in costs from institu- 
tion to institution. 

I can't tell you why. In some it is very high indirect cost. In uni- 
versity hospitals, they are having hard times. I think the efficien- 
cies of different organizations varies rather substantially. 

If everything would be to a unified cost, of course, it is going to 
cause so many more problems for us than if we lump transplant 
patients with people with bladder infections, there is going to be a 
substantial difference between those two if they hit the same diag- 
nostic related group. 

I would urge, frankly, that there be some greater uniformity, and 
yet the risk of creating it is to probably eliminate those groups that 
are a little more costly but that are still making a major contribu- 
tion. 

Mr. Gore. Well, some have expressed concern about the potential 
effect of the prospective reimbursement system on transplant pro- 
cedures and organ procurement, in particular. 

Dr. Pfaff. I would say it could have a chilling effect on those 
who are economically marginal but productive. 

Mr. Gore. Yes. What about the business that Dr. Starzl raised, 
Mr. Denny, about the Aetna letter? This is the insurance carrier 
that is responsible for the Federal kidney program and apparently 
it sent a letter out to institutions participating that implied that 
their insurance coverage might be lost if they harvested extra- 
renal organs in addition to kidneys. Are you familiar with that? 

Mr. Denny. Yes, sir. 

Mr. Gore. Did that have a chilling effect? 

Mr. Denny. I have no direct evidence that it did. 

Mr. Gore. Dr. Pfaff? 

Dr. Pfaff. Well, it creates an impediment. I guess, quite honest- 
ly, there is no way to measure because we don't have accurate data 
on the potential utilization of multiple donor organs and, you 
know, what is being done today. 

In other words, our performance record isn't defined as yet. Fur- 
ther, there are a good number of programs that are just getting 
into multiple organ donations. 



206 

The bottom line is this. Actually, that Aetna did advise us that 
the cost that related to procurement of other than kidneys could 
not be attributed to the renal medicare program. 

We have followed that, but have done it by a variety of means. 
We have participated in the harvesting of both livers and hearts 
and have a very active program in terms of joints that we are 
doing with the orthopedic groups up and down the east coast. 

In many instances we have some sources of funds. Truthfully, in 
dealing with the University of Pittsburgh our costs that particular- 
ly related to liver removal for the purposes of transplantation were 
then passed back to Pittsburgh. 

Heart donor costs were segregated to the point that we could and 
then were sent to the recipient institution. I don't know what the 
payment rate has been, but I suspect after all the conversation that 
I have heard these last several days that, indeed, because dollars 
are such an impediment to individuals who require that kind of 
management, that one of the first things that the recipient institu- 
tion has been paying attention to is, indeed, the donor institutions. 

Mr. Denny. I think that we have to be careful and not imply 
that Aetna is at fault for this. Aetna is merely operating under the 
guidelines established by the Health Care Finance Administration 
following the legislation which was enacted in 1973 and subse- 
quently. 

Aetna is responsible as the intermediary between HCFA and the 
independent organ procurement programs to see to it that the reg- 
ulations governing the financial aspects of organ procurement are 
adhered to. 

Their statement to us that we would not be covered by medicare 
in the event of malpractice, for instance, and a court case involving 
malpractice surrounding organ procurement came also with the 
recommendation that we take out insurance on malpractice liabili- 
ty for extra-renal organ procurement. 

That is, in fact, what we did do. 

Mr. Gore. In other words, it emanated from the Health Care Fi- 
nancing Administration through Aetna? 

Mr. Denny. Yes. Aetna is merely the intermediary. 

Mr. Gore. We are going to have the Health Care Financing Ad- 
ministration on the third day of these hearings along with the Sur- 
geon General. We will be exploring a lot of these reimbursement 
questions at that time. 

A couple of other real brief questions. It seems as if— and I know 
this is a delicate area — it seems often desirable to maintain a po- 
tential donor on life support after brain death has occurred; is that 
correct, Dr. Pfaff? 

Dr. Pfaff. That it is desirable? It is for the purposes of multiple 
organ removal in that, let's say, if somebody is coming from a 
heart transplanting hospital to our institution, it might have a de- 
laying factor, usually in a mattter of hours, not more than that. 

Mr. Gore. But you don't get into a conflict on who pays for the 
cost of care under those circumstances? 

Dr. Pfaff. No. No. Well, for the purpose of the kidney donor, 
from the time of the diagnosis of death, the renal medicare pro- 
gram assumes the cost of continued care. But that is not for long 



207 

because these are unstable individuals in many instances. We are 
anxious to proceed. 

Mr. Gore. But if the extra care is principally needed for the mul- 
tiple organ 

Dr. Pfaff. We are still talking about hours. 

Mr. Gore. But is it charged to the kidney program? 

Dr. Pfaff. Quite honestly, I am not sure. I could imagine that 
potentially being a point of confusion at the time and to the billing 
personnel. I would guess that the receiving institution would 
assume at least part of those costs or the fair share of costs. 

Mr. Denny. Yes, sir. That, in fact, is what happens. We regularly 
pay for a liver anywhere between $1,000 and $3,000, sometimes as 
high as $4,000 of the share of the donor-related charges, the bal- 
ance being picked up by the renal programs. 

Mr. Gore. Let me note that in tomorrow's hearing we are going 
to lead off with the perspective beneficiaries and voluntary agen- 
cies, including Charles and Marilyn Fiske, the parents of Jamie 
Fiske, who will also be with us tomorrow. 

In the second panel we are going to explore indepth the bioethi- 
cal considerations with a number of bioethicists, including the Ex- 
ecutive Director of the Presidential Commission on Bioethics. 

Then we are going to look in the third panel closely at the legal 
considerations, and you got into this a little bit in your testimony, 
Mr. Denny, and I would say for the record to my colleague from 
Illinois that the counsel for the National Conference of Commis- 
sioners on Uniform State Laws will be among the witnesses on that 
third panel. 

Then the third day of the hearings will be a little later on, but I 
wanted to close by thanking members of this panel particularly for 
your contribution here today, and to all of the witnesses who have 
helped us in this first day of the hearings, I want to express our 
thanks and appreciation and with that, the hearing will stand ad- 
journed. 

Dr. Pfaff. Thank you. 

[Whereupon, at 2:45 p.m. the hearing was adjourned, to be recon- 
vened the following day, Thursday, April 14, 1983, at 9:30 a.m.] 



ORGAN TRANSPLANTS 



THURSDAY, APRIL 14, 1983 

House of Representatives, 
Committee on Science and Technology, 
Subcommittee on Investigations and Oversight, 

Washington, D.C. 

The subcommittee met, pursuant to other business, at 9:35 a.m., 
in room 2325, Rayburn House Office Building, Hon. Albert Gore, 
Jr. (chairman of the subcommittee) presiding. 

Mr. Gore. The subcommittee will come to order. 

I would like to welcome all of our witnesses and guests for the 
second day of these 3 days of hearings on organ transplants. 

Yesterday was both moving and disturbing. We were all excited 
and filled with joy to hear about Brandon Hall receiving a liver for 
transplantation. The latest reports from Memphis are that he is 
doing fine. As all patients after such surgery, he is in a critical con- 
dition but is doing quite well. We are all very optimistic and pray- 
erful for his speedy recovery. 

Yesterday's hearing also had some very disturbing testimony, 
however. The testimony from Captain Broderick, as well as others, 
told of people who may die, children who may die, not because the 
necessary medical technology is unavailable, nor because a trans- 
plantable organ is unavailable in some cases, but solely because the 
patient cannot pay for the procedures. 

The third-party payers don't pay for such transplant surgery, 
either. In fact, I found it to be quite shocking that the U.S. Govern- 
ment would not take care of active-duty members of the U.S. Army 
and the other services by providing for transplants for family mem- 
bers because, in the judgment of the Department of Defense, it was 
too expensive. 

I think that policy has to be changed. Without objection, the sub- 
committee will proceed with the plan that we discussed yesterday, 
to contact the Department of Defense and the appropriate agency 
within the Department of Defense, to ask for an immediate change 
in that policy. 

We also learned yesterday that transplant surgery is at the dawn 
of a brand new era. In part, this is because of the advent of a mar- 
velous new drug, cyclosporin, which holds great promise as a 
means of selectively preventing rejection of transplanted organs by 
the body's immune system. 

It also has a great deal to do with the increasing skill and knowl- 
edge in the medical community, of course. However, we also 
learned that we are not likely to have sufficient organs to meet the 

(209) 



210 

demands generated by these impressive advances in medical tech- 
nology. 

Nothing better illustrates what we are here for today, though, 
than our first panel of witnesses. It includes little Jamie Fiske and 
her parents, who, more than any single case, have come to symbol- 
ize the hopes and the despair of many American families who have 
children like Jamie, who were born with incurable liver disease. 

It is estimated that 1 in 20,000 children are born with Jamie's 
condition, biliary atresia, a condition in which the liver lacks the 
ability to excrete waste products. Two of these children were with 
us at yesterday's hearing. 

In fact, I say two, two were at the witness table, but there were 
others in the audience who came with their parents after learning 
about the hearing, and I believe there are some others in the hear- 
ing room today. We welcome you and hope these hearings will be 
of some benefit in the effort to find a solution to the problems that 
you are experiencing. For most of these children, only a liver trans- 
plant offers any prospect of survival beyond infancy. 

Jamie's father, who is with us, felt compelled to mount a nation- 
al media-assisted campaign to secure a liver for his daughter. As is 
quite evident, he succeeded, and Jamie was successfully transplant- 
ed at the University of Minnesota in November, but only after the 
Fiske family had hurdled a series of heart-rendering obstacles, 
which they will describe for us this morning. 

We will also hear from Michele Jones, who is the niece of our 
ranking Republican, Mr. Skeen. I am going to call upon him to in- 
troduce the Jones family in a moment. Michele received a kidney 
transplant in February, after spending more than 2 years on dialy- 
sis. 

Representatives from the National Kidney Foundation and the 
American Liver Foundation will relate their efforts on behalf of 
waiting and past recipients. 

The balance of the morning will be devoted to a careful analysis 
of the bioethical and legal issues surrounding organ donation and 
procurement. 

How can we best satisfy the moral imperative to secure trans- 
plant organs for victims of incurable disease while safeguarding 
the rights and privileges of prospective donors and their families? 
To help us, we have some of the most eminent bioethicists and au- 
thorities in this area. 

I hope we can conclude our day feeling that we have taken steps 
toward understanding and removing some of the obstacles from the 
path of the next Jamie Fiske. 

Before calling on Congressman Moakley to introduce our first 
witnesses, it is an honor to recognize the distinguished ranking 
member of the subcommittee, Mr. Skeen. 
Mr. Skeen. Thank you very much, Mr. Chairman. 
I concur in the points that you have made in your statement, 
particularly in regard to the fact that it is time for us in Govern- 
ment to change the policies to suit the new and advanced degree of 
technology afforded us today in common medical practice in the 
United States. It is now a practice, it is not experimental, and it is 
time for us to tell the insurance carriers, as well as the Federal 



211 

Government, that this change has been made and that they should 
react accordingly. 

I want to particularly thank you for the courtesies and the con- 
sideration that you and the members of the staff, both majority 
and minority, have shown the recipients and other witnesses that 
have been here today. It has been outstanding, you are to be com- 
mended, and I wanted to take a little time to do just exactly that. 

I don't want to spend a lot of time on a statement, but I would 
like to have the personal privilege, first of all, of introducing my 
wife, who is here accompanying my niece, Michele; the gal who 
does the most work keeping me up here and running the best 
ranch in New Mexico. I would like for her to stand up, if she 
would, please. Thank you. 

It is a privilege to have Michele here. It has been 2 months since 
her operation. We have tracked this problem through her lifetime. 
I did not know that she was a recipient until she had actually been 
in the hospital and the transplant had been made. It happened 
that quickly. 

I just want to say to you folks who work in this area, you are to 
be commended because it has been a labor of life. For one who has 
lost a member of his family because there was nothing that could 
be done at that time, I want to say to you that we have come a 
long way. All of you are to be commended, and you have my heart- 
felt thanks for all the things that you do above and beyond what 
your job calls for. It is your hearts that are involved in this process, 
and I appreciate it very much. 

Thank you, Mr. Chairman. 

Mr. Gore. To introduce our first witnesses, I am pleased to call 
upon our distinguished colleague, Congressman Joe Moakley. 

STATEMENT OF HON. JOE MOAKLEY, A REPRESENTATIVE IN THE 
CONGRESS FROM THE STATE OF MASSACHUSETTS 

Mr. Moakley. Thank you very much, Mr. Chairman, members of 
the committee. 

The plight of little Jamie Fiske became known throughout this 
Nation last fall when her parents went before the American Pedi- 
atrics Association conference to appeal for assistance in locating a 
very critically needed liver donor for Jamie. 

Without the national attention received because of this unusual 
request, Jamie may not have been lucky enough to locate a donor 
in time to save her life. Fortunately, however, Mr. Chairman, with 
the help of the medical community, the national coverage given to 
her plight, and the dedication of her parents, a compatible donor 
organ was found and successfully transplanted by a team of very 
skilled surgeons. 

To look at this healthy, happy little girl today one would not be 
able to tell that just a few months ago her young life was in such 
grave danger. Jamie Fiske, Mr. Chairman, I think is the best exam- 
ple of the hope that exists through this extraordinary surgical pro- 
cedure and also of the immense need for a nationwide network to 
match organ donors with those individuals who are in desperate 
need of transplants. 



212 

Mr. Chairman, I am very honored and very proud to present to 
this committee Charles and Marilyn Fiske and, of course, their 
very healthy daughter, Jamie. 

Mr. Gore. Thank you, Congressman Moakley. 

Charles Fiske, if you wish to begin, we are delighted to hear from 
you. Please move one of those microphones over where we can hear 
you better. 

Mr. Fiske. Can you hear me? 

Mr. Gore. We can hear fine, and if Jamie wants to squeal into 
that other microphone, that will be just fine, too. 

STATEMENTS OF CHARLES AND MARILYN FISKE, AND DAUGH- 
TER JAMIE, LIVER TRANSPLANT PATIENT; MICHELE JONES, 
KIDNEY TRANSPLANT RECIPIENT; DAVID OGDEN, M.D., PRO- 
FESSOR OF MEDICINE, CHIEF, RENAL SECTION, UNIVERSITY 
OF ARIZONA HEALTH SCIENCE CENTER; AND THELMA KING 
THIEL, VICE CHAIRMAN AND EXECUTIVE DIRECTOR, AMERI- 
CAN LIVER FOUNDATION 

Mr. Fiske. Good morning, Mr. Chairman, and members of the 
committee. We thank you for inviting us here this morning. 

We would like to introduce ourselves. I am Charlie Fiske, this is 
Marilyn, this is Jamie, and somewhere in this room is Daren, our 
3-year-old son. 

We would like to take a look at three issues that we faced as a 
family. The first and the most pressing issue was the fact that 
Jamie's health was declining. We were told that she had a rare 
liver condition and unless she had a transplant within a very short 
space of time, she would die. 

We felt she was in a fine medical facility at the University Hos- 
pital in Minnesota, receiving excellent care under Dr. Sharp and 
Dr. Freese and a nursing staff and Dr. Najarian and Dr. Ascher, 
but there was nothing they could do except wait for a donor organ 
to be identified. 

The second issue we faced was the whole issue of funding. The 
problem became very apparent when we had gone to our insurance 
company, Blue Cross-Blue Shield, and they had put in writing that 
they would cover the cost of the surgery. Then they notified the 
hospital, after we had received three letters saying they would 
cover it, that they wouldn't cover it. Going back to Blue Cross-Blue 
Shield to get clarification, the best they could offer us would be to 
work out something privately. 

At that point, because of the cost of that, we turned around and 
went back and sat down with different folks, predominantly a 
fellow named Kent Jones from the local Brockton Enterprise, who 
had followed Jamie's story as a human interest story in the area 
we live in. We went through the whole story with him. 

We were able to get a hold of the speaker of the house, Mr. Tom 
McGee, and explained our situation to him. He told us very care- 
fully he would approach Blue Cross-Blue Shield and straighten it 
out. We also went to one of the news stations in the Boston area, 
channel 7, and spoke with a Mr. Tom Ellis, who took the informa- 
tion. 



213 

Through those three men, within 24 hours, Blue Cross-Blue 
Shield had decided that they would cover the entire cost of Jamie's 
medical care. 

That same day, on September 29, Jamie was put on the trans- 
plant list in Minnesota. On top of that, the then Governor of Mas- 
sachusetts, Governor King, approved medicaid approval for Jamie 
for the surgery, which came through October 29. 

So, those two issues — the one, the issue of declining health, 
which we had no control over, and the funding issue — were behind 
us, through Blue Cross-Blue Shield assuming costs for that, as well 
as medicaid willingness to back it up. 

The third issue that we faced was the issue of donor awareness. 
The day that Jamie was put on the transplant list in Minnesota, 
we were told that her vital signs, her liver size, her blood type, 
would be put on a computerized network which would go out to the 
midwestern and the western States, if a donor became available. 

On top of that taking place, both the formal network that was 
set up, individual doctors at the hospital, who had become very at- 
tached to Jamie, contacted their classmates, asking them just to be 
aware of the possibility of a donor being identified. So, both on the 
formal and the informal level, we knew that word was going out. 

The difficulty became between September 29 and the date of the 
operation, November 5. There was that whole waiting period where 
Jamie's health, we were told, was declining very rapidly. We could 
tell from the size of her stomach, from her color, and from the peri- 
odic episodes of internal bleeding that she really didn't have much 
time at all. 

During that period of time I was in Boston and Marilyn was in 
Minnesota, taking care of Jamie on a daily basis and watching her 
die. Through no fault of the medical facility there, because they 
were giving her excellent care, the thing that Jamie clearly needed 
was to have a donor identified and liver implanted in Jamie. 

We didn't feel it was enough to go through the normal channels. 
We knew that her protocol was on the computerized network. At 
that point we went to the New England Organ Bank, and through 
the dean of the medical school at BU, Dr. Sandson, put me in touch 
with Dr. LoGerfo, who wrote to Dr. Najarian. Dr. Najarian, from 
Minnesota, wrote back and said that if a donor was identified in 
the New England area, the team would fly out from Minnesota to 
Boston to identify that liver. 

With that done, we — myself and Marilyn — took a look at which 
direction we could go in. We do know that her name was on the 
computer. We could call up that computer and hear again her sta- 
tistics mentioned on that computer. 

We contacted the AMA in Washington. They said that we should 
get in touch with the American Academy of Pediatrics in Chicago, 
which we did. We called them, specifically looking for the mailing 
list of their 500 pediatric surgeons. 

The organization represents about 24,000 pediatricians, and we 
felt that 500 of those people being surgeons, predominantly neuro- 
surgeons, would probably see a brain-dead child. What we were 
hoping was that by that list, we could personally write letters to 
those particular 500 surgeons. 



214 

As it turned out, their national convention was taking place at 
exactly the same time, in New York City. We asked if we could ad- 
dress that convention in New York City. There was a lot of hesi- 
tancy from the academy, and I think rightly so, because it was 
their convention and I was not a doctor. 

Again, we went back to them and said that our problem was 
symbolic of a lot of other children needing help, not only with 
livers but with other organs. The response that we got back was 
well, we will think about it, et cetera. We were not getting a clear 
answer back. 

So, with that, we turned around and went back to the same 
people in the media who had followed Jamie through the Blue 
Cross-Blue Shield incident. At that point, we went to other media 
both within the Boston area and also through the national net- 
works—ABC, NBC, and CBS— and just presented the problem that 
we had, that we were not getting a clear answer back from the 
academy. 

On top of that, we sat down and looked at probably people that 
could help us. We went, first of all, to Congressman Moakley's 
office and asked if he could ask the academy for us. Very clearly a 
response out of Congressman Moakley's office was yes, we will call 
to see if we can get a clear answer. 

The then Lieutenant Governor of Massachusetts, young Tom 
O'Neill, clearly became involved in it. Senator Kennedy's office, we 
asked them the same thing. Very clearly Senator Kennedy's office 
responded. Senator Tsongas' office very clearly responded, asking 
that same question. The Speaker of the House, Mr. O'Neill, very 
clearly asked the academy, can this family get up in front of you. 
Through a media awareness and political support, there was a 
clear decision made back to allow us to speak to the academy. The 
address was on the last Thursday of October, October 28. Our 
appeal was basically for Jamie, and also mindful of the fact that 
not only we were waiting, but many other children like her were 
waiting. 

A young family in Utah was sitting watching television that very 
same night, on that Thursday night. They had two children, both 
about a month apart from the ages of our children. Their young 
son, Jess, was involved in a car accident the following Tuesday. 

The family remembered that national telecast that had taken 
place the previous Thursday. They had approached their doctors 
and asked if it was possible that the liver of their son, Jess, if it 
was compatible, there was a family, they did remember, that had 
gotten up the previous Thursday. 

Phone calls went from Utah to Pittsburgh. Pittsburgh identified 
that there wasn't a candidate there that could benefit from it, 
simply because they had done a number of operations that week. 
The call then went from Pittsburgh to Minnesota, Minnesota 
clearly responded, and went to Utah and retrieved the organ, the 
liver of Jess Bellon. On November 5, Jamie received a new liver. 
What I would like to do— we only have one copy of this, but we 
will submit it for the record. It is pictures that very clearly demon- 
strate the before-and-after effects of what happened from before 
November 5 and what happened afterward. 



215 

Actually, the best example of a healthy operation and a success- 
ful transplant situation is Jamie right now. When she left the hos- 
pital, she was 14 pounds in December, and she is now 24% pounds, 
doing very well, and doing some of the things she couldn't do when 
she was so sick. 

The reason for presenting all of that is that there were a number 
of people involved in Jamie's situation, numbers of media people, 
numbers of political people, numbers of residents of Massachusetts, 
numbers of residents of Minnesota, who became directly involved 
in it through telephone calling and asking and being aware. 

As a result of that kind of effort, a number of things happened 
that we have outlined as results. One is that right after the oper- 
ation the donor family, through their social worker, Jayne Taylor, 
asked if we would get in touch with them. The donor family had 
initiated that process because they had heard that national tele- 
cast. 

We talked with them the following Tuesday and Wednesday. 
Most of their conversation was spent asking how Jamie was doing. 
We have had contact with them, and we feel that the Bellons of 
Utah are Jamie's extended family and they share in Jamie's good 
health as much as we do. They did it at one point in time, what no 
other family in the United States was able to do it; that is, offer 
Jamie an opportunity to live. 

Beyond that, what has happened is that individual families have 
called us. We could go through a list of names, everywhere from 
California to Mississippi, even to the Hall family that we had 
planned on meeting here today. Our feeling was hopefully we don't 
meet you here for the right reasons. It was so good to see that take 
place yesterday, with that transplant. 

Individual families have contacted us. Strangely enough, it has 
not just been families of liver patients. It has been families who 
need corneas, who need bone marrow transplants, who need kid- 
neys, who need other organs for transplant. 

So, some of the same situations that we faced in terms of Jamie's 
declining health, other families are going right now through that 
same experience. We have had that kind of ongoing contact with 
families, if for no other reason than to say it does work, there is a 
possibility of hope. 

On the State level in Massachusetts, the Governor of Massachu- 
setts, Michael Dukakis, proclaimed March as Organ Donor Aware- 
ness Month. We are told that on the national level there is an 
effort to declare one of the months or one of the weeks as Organ 
Donor Awareness Week. 

Also, in Massachusetts the AMVETS, who are traditionally in- 
volved with blood drives, became aware of Jamie's situation. They 
set up on March 29 an organ donor awareness drive in conjunction 
with their blood drive. Involved in that group were all the organ 
banks in New England. 

It is interesting because the McKeon post in Dorchester is the 
largest AMVET post in the country. The State commander, Robert 
Medairos, became involved with it and is taking that project, organ 
donor awareness, to the national level at his national convention, 
which is coming up I want to say in Florida within the next 2 



216 

months. He is taking that on as a project that AMVETS nationally 
can get involved with, much like their blood drive. 

It is very encouraging because that group has connections across 
the country, and their willingness to do that as a volunteer organi- 
zation has an impact for people not only waiting for livers, but for 
other organs as well. 

Finally, one of the results that has happened is there has been 
an ongoing contact that we have had with the White House. 
During the ordeal with Jamie, the President had written to us 
twice, one a letter to us commenting on the fact that the Bellon 
family did a caring and generous thing in terms of the gift of their 
son's liver to Jamie, and also gave best wishes to Jamie. Also, the 
President had taken the time to write Jamie a short note at Christ- 
mastime, a "Dear Jamie" letter. 

Since that time we have had an ongoing contact with the White 
House. They have asked us to call other families, again not only 
families of liver transplant patients, but bone marrow transplanta- 
tions and kidney people. That kind of behind the scenes thing has 
been taking place. 

We raise all that because the issue for us is certainly not parti- 
san. We have got local politicians involved in it, both sides of the 
aisle, on the congressional level, on the senatorial level, at the 
White House level. It hasn't been a partisan type of issue, it has 
been an issue about caring for people, people caring for people. 

So, it has been very encouraging, when you get various phone 
calls, and it doesn't really make any difference which way I voted 
or whether Jamie is whatever, a Democrat, Republican or Inde- 
pendent. The fact is she needed life. 

That kind of support has presented us with some of the deficien- 
cies in the system, the three problems we faced. One, the declining 
health, we had no control over. The issue of funding, there is input 
into that. In Massachusetts, Blue Cross-Blue Shield did pay for it, 
as well as Massachusetts medicaid. 

The overriding problem is donor awareness. Why is it that we 
had to go as a family to some of the lengths we did to involve all 
levels of government, all levels in contact with media, phone bills 
that were exorbitant, just to get word out, to have a family that 
lives in Alpine, Utah, watching TV, not knowing where 
Bridgewater, Mass. is, and responding accordingly? Fortunately, 
that gift of life saved our daughter. 

What we feel needs to take place, again based on our experience. 

One is that there has to be a centralized type of organ donor 
awareness institute or program, both on the regional and on the 
national level. The way that would be set up would be that in each 
one of the regions the specific responsibility of that program would 
be organ donor awareness and public education. 

The problem is that the local organ banks — and we have run this 
by the New England Organ Bank, the Eye Bank, the Kidney Foun- 
dation of Massachusetts, and the Massachusetts General Hospital 
Bone Bank — don't have the ability to do public awareness. It is not 
a reimbursable cost. 

We presented the idea of them, with a separate organization, 
doing organ donor awareness, and they bought it wholeheartedly. 
They thought it was a good thing that they could match up with. 



217 

To put some teeth into it, what would be needed would be that 
any hospital receiving federal money or clinic, that they institute 
an organ donor awareness program within their hospital, not some- 
thing very costly at all, but that they raise the issue on the hospi- 
tal level. 

Second, that every single medical school that receives federal 
funding of any sort be required to institute organ donor awareness 
seminars as a course of study within their medical school. 

Third, any group that is receiving law enforcement money on the 
federal level or on the local level, that in their police academies, 
there be training officers to be aware to look on a driver's license 
for the symbol of universal donor on the person's license. 

We would encourage that to take place, again because organ 
banks are not in the business of public awareness. That is the big 
problem that we faced, is getting word out. We had to go through 
political people, we had to go through media people to get word 
out. If there was something, again, at the regional and national 
level to do that. Then, I think the problem that we faced, the great- 
est one we would be able to look at, would be her health. Other 
organizations, like the AMVETS, have picked that up and are will- 
ing to take it forward. 

I think by that kind of effort the feeling of waiting, the feeling of 
hopelessness that we went through as a family, at least there 
would be something that we could say is in place. 

The other issue that comes up, of course, is the issue of matching 
up proper donors with proper recipients. That is a whole communi- 
cations system that needs to be put in place, so that the proper 
donor gets matched up on a needs basis. The awareness issue is the 
one that we clearly have been faced with. 

Marilyn, do you have anything to say? 

Mrs. Fiske. I think mainly, just over the past months, that Char- 
lie have shared everything that we have spoken about today. It just 
involves very much the heart that has gone into this. 

I think over the past months it is very difficult to share some of 
the emotional kind of ends, the pressures and the strain, but in 
fact it is not necessary today because we are just so elated and 
thrilled to have Jamie home with us and to watch she and her 
brother in action together at home. 

It is the dreams, maternally and paternally, that Charlie and I 
had when we were expecting Jamie and had to suppress them be- 
cause there were so many medical priorities that took over. All of a 
sudden we could feel ourselves starting to unwind and starting to 
dream the thoughts and the hopes that we had as a family. 

Since the past few months, in Minnesota, we have seen too 
much, and we have been someplace, that we feel compelled, that 
we have to be able to help other little children, help the adults that 
we met in Minnesota. 

I think, along with Charlie, our main goal and our hopes would 
be to set up some kind of a national awareness program just to al- 
leviate the strain, the additional strain that families have to go 
through. 

Our hearts and hopes are with the parents in this room of chil- 
dren and the adults that may be in this room also, who are going 
through similar kinds of ordeals. We also have such a hope in our 



218 

hearts for all of them, and we certainly hope and thank you for 
inviting us here, to be able to see something come from this. 

Thank you. 

[The following material was submitted for the record:] 



219 



TESTIMONY FISKE FAMILY 
Committee on Science and Technology 
Sub-Committee on Investigation and Oversight 
April 14, 1983 9:30 AM Rayburn Office Building Rm. 2325 
OUTLINE 

1. Review of Jamie Fiske's health condition. 

2. Medical steps taken by University Hospital, University of Minnesota 
both formal and informal. 

Medical support of effort to identify potential donor for Jamie. 

3. Waiting period between time of placement on transplant list and surgery. 
Personal reflections and deficiencies in system. 

4. Steps taken to involve New England Organ Bank, American Academy of 
Pediatrics, political support and media awareness. 

5. National alert through American Acedemy of Pediatric's convention and 
the response of the Bellon family of Utah. 

6. Results: a. Contact with donor family. 

b. Problem of organ donor awareness through nationwide 
contact with individuals needing transplant surgery. 

c. Donor awareness Proclamations on State and Federal level. 

d. John P. McKeon Post No. 146 Amvets - Organ Donor Awareness 
Drive, local, State and National impact. 

e. White House response. 

Recommendations: To be presented at testimony on the 14th of April 




Jamie Fiske Spring 1982 






220 




October 1982 



2 weeks before transplant operation, November 5, 1982 




. ',< 




W ' 







* . > 



January 1983 



221 



3okn V. JHcJCon Tost JVo. 146 *4> 



rnvets 




BLOOD DRIVE & ORGAN DONOR AWARENESS DRIVE 
MARCH 29, 1983 3:00PM to 8:00PM 

The Address Ceremony will be held between 3 & 4PM. 

On this day the John P. McKeon Post #146 Amvets will conduct its 
annual Blood Drive coordinated by the American Red Cross. In 
response to Governor Dukakis's Proclamation of March as Organ 
Donor Month, the Post on this same date will conduct an Organ Donor 
Awareness Drive. The following groups and individuals have whole- 
heartedly agreed to participate with the Post in this drive. 



New England Organ Bank 
New England Eye Bank 
MGH Bone Bank 
Shriners Burns Institute 

Skin Bank 
Jamie Fiske, Liver Transplant 
Recipient 



National Kidney Foundation of Mass. 
New England Renal Network 
Support Group for Parents of 

Children with Liver Disease 
Mr. Robert Mederios, State Amvet 

Commander 



For further information contact Service Officer James F. Mullin at 
436-2911 between 9 & 4. 

Michael J. Mylett 
Commander 



The Drive will take place at the Post located at 4 Hill Top Street 
Dorchester. 

4 HILL TOP STREET, DORlHESTER. MASS 02124 617-436 2911 



23-029 O 



83 



15 



222 



Jokn V- JWcJKeon Tost JVo. 146 tdwt. 




PRESS RELEASE 



The John P. McKeon Post No. lU6 Amvets, the 1 
in the country, in conjunction with the State 
Robert Medairos and the State Department of A 
an Organ Donor Awareness Drive to he held on 
the annual blood drive. Present at the Drive 
Chiampoli, National Amvet Executive Committee 
Reardon, President of the Department of Mass. 
This Drive is in response to the Proclamation 
S. Dukakis declaring March as Organ Donor Mon 
Awareness Drive has received the full support 

Organ Bank, the National Kidney Foundation of 

Eye Bank, the New England Renal Network, the 

Bank of the Shriners Burns Institute and the 

of Children with Liver Problems. This cooper 

a clear example of community service that may 

National Amvets organization and other groups 

problem of organ donor awareness. The Amvets 

been involved with blood drives. The McKeon 

Organ 'Donor Awareness Drive will benefit thos 

are currently waiting for transplant surgery. 

Motor Vehicles representing the Governor will 

the Post for its effort. 

Jamie Fiske, liver transplant recipient, whose search for a liver 
donor received national attention will be present with her family 
at the Post on this day. The Fiske family is *«£*"*" *°J ne 
supportive of the Amvet's willingness to respond to this genuine 

health need. 



argest Amvets Post 

Amvet Commander 
mvets has initiated 
March 29th along with 

will be E. Frank 

member and Thelma 

Amvets Auxilary. 

of Governor Michael 
th. This Organ Donor 

of the New England 

Mass., the New England 
MGH Bone Bank, the Skin 
Support Group of Parents 
ative effort establishes 

be adopted by the 

that can address the 

have traditionally 
Post feels that this 
e many patients who 
The Registrar of 

formally recognize 



For further informat ion . call : Service Officer J gJ" 2 Ji 1 Mullln at 



State Department of Amvets 727-2972 



The Drive will take place at the Post located'at h Hill Top Street, 
Dorchester between 3:00 and 8:00 PM. The Address Ceremony will be 
held between 3:00 and U:00. 

4 Hill TOP STREET, DORCHESTER. MASS. 02124 617-436-2911 



223 

JoL °P. Jlic^Keon 'Post JVo. 146 ^4mv e ts 




March 29, 1983 
ADDRESS CEREMONY 

General Introduction Commander Michael J. Mylett 
Formal Recognition to Governor Michael S. Dukakis through his 

representative Registrar Alan A. Mackey 
Review of Official Correspondence Commander Mylett 
Brief Summations 

Robert Medairos, State Amvet Commander 

E. Frank Ciampoli, National Amver Executive Committee 
Thelma Reardon, President Dept. of Mass. Amvets Auxilary 
Benjamin A. Barnes M.D., Secretary-Director New England 

Organ Bank 
John Cur ley, Executive Director, National Kidney Foundation 

of Massachusetts 
Phillip Walters, Skin Bank Shriners Burns Institute 
Jeff West, Support Group for Parents of Children with 

Liver Problems 
Valerie Belcher, Executive Director, New England Eye Bank 
Jamie Fiske, Liver Transplant Recipient 

Concluding Remarks Commander Mylett 

4 HIU TOP STREET. DORCHE'.IER. MASS 02124 617-436 2911 



224 



Sl|? dnrnmanwealtlj nf JKaBBarljuaFttB 



By His Excellency 

MICHAEL S. DUKAKIS 

Governor 

A PROCLAMATION 
1983 



WHEREAS: 



WHEREAS: 



WHEREAS: 



WHEREAS: 



March has been proclaimed Organ Donor Month in the Commonwealth 
of Massachusetts; and 

The Registry of Motor Vehicles maintains an Organ Donor Program 
and is committed to its implementation ; and 

All citizens of the Commonwealth have been urged to take cognizance 
of that event and participate fully in its observance; and 

The John P. McKeon Post No. 146 Amvets in conjunction with State 
Department of Amvets has willingly responded to that Proclamation 
through the initiation of an Organ Donor Awareness Drive to include 
the New England Organ Bank, New England Eye Bank, Skin Bank of the 
Shriners Burns Institute, National Kidney Foundation of Massachusetts, 
New Engalnd Renal Network, Support Group for Parents of Children with 
Liver Disease; and 

The John P. McKeon Post No. 146 Amvets and the State Department of 
Amvets have fully demonstrated a commitment to educate the general 
public through an Organ Donor Awareness Drive; and 

The John P. McKeon Post No. 146 Amvets with the assistance of the 
State Amvet Commander and his staff have demonstrated leadership and 
concern for the health of the citizens of the Commonwealth and have 
set an example of positive response to a genuine community need; and 

The Amvets already have a commitment to community service and have 
established a precedent that may be emulated on the national level 



NOW, THEREFORE, I, MICHAEL S. DUKAKIS, Governor of the Commonwealth of Massachusetts, 
do hereby give full recognition to the John P. McKeon Post No. 146 
Amvets for its initiative and leadership in establishing an 

ORGAN DONOR AWARENESS DRIVE 

as a response to my Proclamation of March as Organ Donor Month. 

Given at the Executive Chamber in Boston, this 
twenty-fourth day of March, one thousand nine 
hundred and eighty-three, and of the Independence 
of bfle United States of America, the two hundred 
seventh. 



c. 



By His Excellency the Governor 





nnv a v tc 



CHAEL S- DUKAKIS 



I 





GOD SAVE THE COMMONWEV.TH OF MASSACHUSETTS 




225 



DEPARTMENT OF MASSACHUSETTS 

AMVETS 

AMERICAN VETERANS Of WORLD WAR II, KOREA AND VIETNAM 



durtand »y Ad 
ol Congms 
Jul, 13, 1947 



ROOM 542, STATE HOUSE 



BOSTON. MASSACHUSETTS 08133 



T»l.phon«, 727-2972 



April 5, 1983 



Mr. Charles Fiske 
100 Bayberry Ave. 
Bridgewater, Ma. 02324 



Dear Charlie: 



1' 
can V 
of th 
for s 

Y 
and t 
persi 
ved i 
about 
one w 



his letter is to thank you, and Jamie on behalf of AMVETS (Ameri- 
eterans of WW II, Korea, and Vietnam) for making AMVETS aware 
e need to show people how important it is to donate a vital organ 
omeone, somewhere, lying in bed waiting to be helped. 

ou as a father of a loved one, have gone through this experience 
orment of one closed door after another. If it was not for your 
stence, and your love for Jamie, we as AMVETS would not be invol- 
n such an important program of telling people throughout the counts 
Organ Awareness", and hew to donate a vital organ so that some- ' 
ill 1 ive . 



^f am^c tn e State Commander was proud on March 2yth of the turnout 
of AMVETS, arid people who care, and the coverage we received by the 

S^p?'-^' A1S °' the fact that %t was held at the largest 
AMVE1 Post in the country, the .John P. McKeon Post #146. 

As a state Department, we have endorsed this as a Program in 
conjunction with our Blood Drive. " ' 

I am a candidate for Nation.-.! Vice Commander of Programs If I 
am successful in 1 his endeavor, i hope to make "Donor Awareness" a 
Program on a National level . 



' incerely 



RAM/vi 



Robert A. Medal ros, 

State Commander 

Department of Massachusett: 



WE QoMtfkt TOGETHER NOW, LETS BtuJd TOGETHER 



226 




J fa v&mmenavetww 6& <Jvla4UuwtUei& 



600 Wu&*f*» SSL*. 3i«to~ OS/// 



THOMAS H. SPIRITO 
Commissioner 

October 29, 1982 



Mr. and Mrs. Charles E. Fiske 
100 Bayberry Circle 
Bridgewater, MA 02324 

Dear Mr. and Mrs. Fiske: 

The Department of Public Welfare is happy to inform you that based on the 
information submitted on behalf of Jamie, approval is given for payment of her 
medical treatment and for a liver transplant to be done at the University of 
Minnesota Hospital. 

Since Jamie has Blue Cross/Blue Shield coverage, all claims must first be 
submitted to the private insurer. Payment to the hospital can only be made by 
Massachusetts Medicaid at the rate authorized by Medicaid in Minnesota, less any 
payment made by Blue Cross. 

Physicians who customarily bill private patients for their services may be 
reimbursed according to the Massachusetts Medicaid Fee Schedule for physicians, 
less any payment made by Blue Shield. 

Medicaid Provider Applications will be sent to the hospital separately. 
After a provider number is obtained, complete policy and billing instructions 
will be sent. 

We wish Jamie a beneficial outcome of her treatment. 



._£incerel,yf^ 

is H. Spipito 
Coninissioner 




THS:JK:mv 



cc: Brockton CSA 

John S. Najarian, M.D. 

Annette Jorbin, University of Minnesota Hospital 

Joan Keefe 



227 



Blue Cross .-;: , 

ol Massachusetts •» \" 

J 



100 Summer Street 
Boston. MA 02106 



October 1, 1982 



Hospital Administrator 
University Of Minnesota Hospital 
420 Delaware St. S.E. 
Minneapolis, MN 55455 

Re: Jamie Flske - Identification No. 7324233 

Dear Sir: 

Hospital expenses incurred, for services related to the liver 
transplantation for Jamie Fiske, will be paid for by Blue Cross. 
Although the terms of our contract exclude coverage for liver 
transplantations , due to the extenuating circumstances in this 
particular case, we have made an exception. 

All hospital billings should be directed to Blue Cross and Blue Shield 
of Minnesota for processing. 

I sincerely apologize for any inconvenience this may have caused you. 




Philip A. Litos 

Hospital Claims Department 

cc: Patient Account Manager 

University of Minnesota Hospital 
Mr. Charles Fiske 
Ms. Annette Jorbin 



228 

Mr. Gore. We appreciate so deeply your willingness to share 
your experiences with us. 

We are going to have some questions, if you can be patient with 
us for a moment. Our procedure is to have the panel testify and 
then come back for questions. 

There is a common thread here. Michele Jones benefitted from 
the same sort of elevated awareness that led to an organ for Jamie. 

Mr. Skeen, would you like to introduce Michele? 

Mr. Skeen. Mr. Chairman, I think that you could go on and in- 
troduce her, so we can get on with the testimony, but thank you 
very much. 

Mr. Gore. Michele Jones was awaiting a kidney transplant when 
there was a television show that highlighted the problems of organ 
procurement. A young person was watching that show and made 
the comment that he would like it to be known that he would have 
his organs donated if there was ever a tragedy. As fate would have 
it, not long afterwards there was an accident, and that is what led 
to Michele's operation. 

Michele, could you describe your experiences for us? 

Ms. Jones. Thank you, Mr. Chairman, members. 

My name is Michele Jones. I am 22. I just graduated from Lub- 
bock, Tex., Texas Tech University. 

My parents were told when I was 4 years old that I had abnor- 
mally small kidneys. In 1972 they diagnosed this as bilateral renal 
hypoplasia manifesting itself predominantly from renal or tubular 
defects. 

At this time, they told me that I should have no children. They 
mentioned that I would go on dialysis. I had no idea what it was. I 
had no idea what the transplant would include. As far as I knew, I 
would go straight from the way I was living then right into a trans- 
plant. I didn't know you would have to go through finding a donor 
through tissue typing or anything like this. 

In August of 1978 additional reviews were made, and they decid- 
ed that renal disease was either hereditary or congenital, with re- 
gional scarring. 

My attitude on life at this time had turned very negative. At 12 
years old you really don't think about having children, but it is 
kind of in the back of your mind. As I grew older, the more I 
thought about it, the more it was like a sword. It just got worse 
and worse, until it made my attitude towards marriage and toward 
life in general very, very bad, very negative. I really didn't care for 
it. I didn't want anything to do with it. I didn't want to take the 
chance of passing it on to my kids. 

Basically, I had very bad mood swings. It affected my mental out- 
look very much. In my junior year in college, my kidney really 
started getting bad. My skin started turning yellow. My mental 
process, I couldn't think as clearly. I had to sleep all the time, it 
seemed like. 

On July 1, 1981 I got kicked in the face by a horse, which had 
nothing to do with my kidneys quitting. So, I was in ICU. When 
the doctors came in and started cutting on my wrist to put a shunt 
in, I had no idea what they were doing. I didn't know what they 
were going to do when they hooked me up to a machine. I didn t 
know what it was supposed to do. 



229 

When I finally could start talking, so I could ask them questions, 
they told me what dialysis included, that it sent your blood 
through a machine to purify it, to get rid of the waste products 
that your kidney was supposed to get rid of and didn't. 

Mentally, it was a very big adjustment, going from being able to 
d0 'anything I wanted to to being restricted to twice a week going to 
a dialysis center, 4 hours at a time. I had to work my school sched- 
ule around it, my work schedule, life schedule. If I didn't feel good 
when I got off the machine, I had to cancel anything I had planned 
for after that. 

Some of the side effects of dialysis were if they got you too dry 
your legs would cramp. You might have nausea, headaches, dizzi- 
ness. Sometimes when I was driving home after dialysis I would 
have peripheral blindness. I couldn't see to the sides. 

I got this feeling when I was driving down the road that I could 
run over anybody and I would never feel it. It was a very strange 
feeling, to know that you could do something like that. It was like I 
couldn t be hurt. That was the sensation I got after dialysis some- 
times. 

My mental attitude improved greatly during my dialysis treat- 
ment time, the years I was on it. I had a better outlook. It made 
me grow up, I guess, in the sense I had to learn to adjust to many 
life situations; to plan on something that had to be changed, then I 
could do it more easily. 

One of the problems I noticed on dialysis— not on the machine, 
actually— was in traveling, you had to let a center know at least 
two weeks in advance that you were going to go there. Sometimes 
you couldn t get on, they didn't have room for you, they didn't take 
out of state or out of town patients. Sometimes you didn't let them 
know far enough ahead of time, and many times the towns didn't 
have a dialysis center. 

So, if I had continued on dialysis I think this would have affected 
my working because if I had gone into being a sales representative, 
as I was going to, this would have limited the regions I could have 
traveled, the places I could have gone. I would have worked com- 
pletely around this scheduling of dialysis. 

Also, when I was on dialysis they used a Gortex graph in my 
arm and it had clotted off three times since I had had it put in. 
lh^ last time was the Monday before I got the transplant. 

That was another thing. Eventually I would have run out of 
places for them to put graphs or fistulas. They would have had to 
go subclavian, and then I would have had to stay in the hospital. 
Other than the inconvenience, I could have stayed on dialysis, 
probably, except for mentally it was getting to me very much 

Before the transplant, I did some living-related blood tissue 
typing. We had gone through this for over six months. We were 
having various problems with the center I was working with in 
Dallas, getting this all worked up. They didn't tell us what to 
expect on a transplant, where the kidney was going to go, or any- 
thing like this. 

On January 1, I did get on the cadaver list. I tried to get on there 
before, but they said I could not get on the cadaver list and be 
working up the family-related at the same time. 



230 

In January I got on the list. On February 4, they called me up 
the first time and told me I had a kidney. I told them that I was 
sick, I had a cold, and they would not let me have it. They said, 
"We have other people that could benefit from this kidney. We will 
check with them first." They went ahead and checked and found 
one that was acceptable. 

I would like to say, here, that kidneys like many other organs 
are not that easy to come by. I was lucky. I was considered an easy 
match. I had not had many blood transfusions. I had not built up 
many antibodies. Many transplant patients have had blood transfu- 
sions, and major operations which make it harder to match them. 
I would also like to say that the emergency room doctor can 
make the difference in usuable organs. A person may come in to 
emergency, declared brain dead, and the doctor may not keep the 
person alive. Where if the doctor had kept the person on a life sup- 
port system; as they did my doner, the organs that the person 
wants donated can be. A lot rests upon the emergency room doc- 
tor's shoulders as to whether organs are usuable or not. 

The 15-year-old boy who donated his kidney was watching 
"Thursday's Child" on February 1, the week before he was legally 
declared dead, and he donated both of his kidneys, which went to 
Dallas, his corneas stayed in Tyler, they did use some of his skin at 
a burn center, and his heart went to St. Louis. 

When they called me Monday morning, I was on dialysis. They 
said, "You have got a kidney. Get here as soon as you can." It took 
us three hours to get to the Lubbock airport and then fly to Dallas. 
Blood typing was done again. It took 4 to 6 hours for them to do 
that, before they could say a definite yes or no with this kidney. 
I had the surgery done at 9 o'clock in the morning, Tuesday 
morning, on February 8. There were no complications. It took 
about 4 hours. The doctor said I had a 78-percent acceptance rate 
at that time, and it will increase as the years go on. 

These are some of the side effects of some of the medicines I am 
taking, which are Prednisone and Imuran. Short term, with 
Prednisone you develop a moon face, your acne increases, like you 
are going through being a teenager again, you gain weight, your 
appetite is increased, but as the Prednisone levels are decreased, 
most of these effects also decrease. 

Long term, they told me that I could develop skin cancer much 
easier, that whenever I did go out in the Sun I had to put a Sun 
screen on; that I would have joint problems, basically hip joint 
problems, that they could replace that; that I would also have the 
possibility of coming up with cataracts, which they could also fix. 
Mentally after this I think I have been much better. My mood 
swings have completely gone. I have a much better attitude on life. 
I look forward to it now. I see challenges. Because I have overcome 
this much, surely nothing else could stop me. 

Some of the things I have to watch after, since I have had the 
transplant, is my immune system is much lower. Especially the 
first month or so I watched who I was around, I stayed out of 
crowds, and I kept a very good check on my temperature and 
weight gain. 

Something that I am going to have to watch from now on is my 
blood pressure, which I take twice a day, and my temperature, 



231 

which I take twice a day. I check my weight every morning before I 
eat. 

As far as eating is concerned, while I was on dialysis I was on a 
restricted diet. I was on a low potassium, no salt, high protein diet 
plus liquid restriction of 500 cubic centimeters plus output. After 
the transplant I was still restricted on the salt and still on high 
protein. No I have to eat foods with potassium to keep up with my 
body's needs. The liquid restriction is gone, now I have to drink as 
much as I can, in order to keep my kidney flushed, and to keep my 
output up. Basically the diet has changed a fair amount in that 
now I can eat many more foods than I could before, especially 
fruits. 

I have to stay on my Imuran and Prednisone, as far as I know, 
for life, every morning, I can't skip at all. If I do skip, the possibil- 
ity of rejection goes up very quickly. Dr. Pedro Vergne, who is my 
nephrologist, said if my temperature got above 100, first to call 
him, and they would check to see if it wasn't a rejection before 
they doctor me for anything else. 

I don't anticipate having any problems. I haven't really had any. 
I have been in and out of the hospital three times since the oper- 
ation, but none of them were kidney-related that they could figure 
out. 

As far as plans for later on, I plan on getting a sales representa- 
tive job with Marion Laboratories and continuing as I should, now 
that I am what I consider normal. 

Mr. Gore. Thank you very much, Michele. We will have some 
questions for you in just a moment. 

We would like to hear from the president of the National Kidney 
Foundation and from the executive director of the American Liver 
Foundation. 

Dr. David Ogden, in addition to being president of the National 
Kidney Foundation, is professor of medicine and chief of the renal 
section at the University of Arizona Health Science Center. 

Dr. Ogden, without objection your entire prepared statement will 
be put into the record in full. We invite you to proceed. If you care 
to summarize any of your statement, feel free to do so. 

Dr. Ogden. Thank you, Mr. Chairman, and members of the com- 
mittee. 

I appreciate the opportunity to speak to this committee on behalf 
of the thousands of lay and multidisciplinary professional volun- 
teers of the National Kidney Foundation, which is the leading vol- 
untary health organization dedicated to the needs of people with 
kidney and urologic diseases. 

I would comment in four areas. I should indicate that my com- 
ments pertain particularly, if not entirely, to kidney disease, which 
is the area in which we have particular interest and expertise. 

First, the role of the National Kidney Foundation in organ pro- 
curement; second, the present status compared to the potential of 
organ procurement; third, the results of a recent Gallup organiza- 
tion survey concerning the attitudes and opinions of the American 
public toward kidney donation; and finally, measures to enhance 
organ donation in the United States, as suggested by both our 
Gallup survey and by the Foundation membership. 



232 

The National Kidney Foundation organ donor program began 15 
years ago with the support of the Uniform Anatomical Gift Act. 
Since then, the foundation has printed and distributed over 30 mil- 
lion donor cards, including 900,000 cards which were distributed 
through a cooperative effort with the Lutheran Church. 

The Foundation and its more than 50 affiliates actively support- 
ed the individual State driver's license organ donor checkoff laws, 
which now provide for people to donate organs in all 50 States, or 
to indicate their willingness to donate organs. The value of this 
option in enhancing public awareness of organ donation has been 
tremendous, as evidenced perhaps from the Gallup survey. 

The Foundation conducts an active and ongoing program in sup- 
port of kidney transplantation and organ donor publicity, both 
through its own publications and through broader media. Recent 
efforts include arrangements by our affiliates of numerous radio 
and TV appearances and over 100 newspaper articles which de- 
scribe Arnold Beher's "Gift of Life," 9,000 mile, zigzag, cross-coun- 
try bicycle tour with a bicycle powered by a transplanted kidney. 

It includes Foundation support of the U.S. team's participation 
in the 1982 Fourth International Transplant Olympics held in 
Athens, Greece, and includes the just completed organ donor blitz, 
in which a number of members of Congress signed organ donor 
cards and in which the President of the United States met with 
National Kidney Foundation officials and endorsed the concept of 
organ donation. 

The present status of organ procurement can be judged from the 
number of kidney transplants performed compared to the number 
of kidneys that are potentially available and suitable for transplan- 
tation. 

In 1981 there were nearly 2 million deaths in the United States 
from all causes. About 60 percent of these deaths occurred in a lo- 
cation that was potentially accessible to organ procurement. We es- 
timate that of those, only 1.5 percent would meet existing criteria 
as potential organ donors for kidney transplantation. 

I would like at this time to make the point that the criteria for 
potential donation of other organs are quite different, so the fig- 
ures don't really pertain to hearts, livers, or other organs. 

Therefore, about 18,000 dead people might have contributed two 
kidneys each, providing 36,000 potential kidneys. Of those, for var- 
ious technical reasons, no more than about 75 percent, or perhaps 
27,000, might be considered actually transplantable. An additional 
10 percent wastage might be experienced in locating a suitable re- 
cipient. 

So, there might have been 24,000 kidneys available for actual 
transplantation. In fact, 3,425 cadaver kidneys were transplanted 
in 1981. That is about 14 percent of the potential organs available. 
It is estimated that at any point in time, there are 6,000 to 8,000 
U.S. dialysis patients waiting for cadaver kidney transplants. 

The Gallup organization survey, commissioned by the National 
Kidney Foundation, was conducted from January 14 to January 22 
of this year. Of a nationally representative survey sample of almost 
1,600 people age 18 and over, 93 percent had heard of organ trans- 
plants and 76 percent had heard of organ donor cards. Eighty-five 



233 

percent of respondents were aware that organs were only some- 
times or rarely available when needed. 

Thus, the American public is remarkably aware of the issue and 
of the problem. Perhaps more remarkably, 83 percent of those 
aware of organ transplants indicated that they were very or some- 
what likely to donate the kidneys of a loved one, although only 40 
percent were very or somewhat likely to want their own kidneys 
donated after death. 

The reasons most often cited for not wanting to donate their own 
kidneys were, "I never really thought about it," 20 percent of 
them, and "I don't like the idea of cutting me up after I die," an- 
other 20 percent. 

Of those who are very or somewhat likely to donate their own 
kidneys after death, 31 percent had signed a donor card. If the 
sample is truly representative of the U.S. adult population, then 
approximately 21 or 22 million adults have actually signed donor 
cards. 

It is apparent that the shortcoming in organ availability is not a 
lack of public awareness or public education. It is not a lack of 
public willingness to grant permission for organ donors after death. 
Indirectly, then, the survey indicates that the greatest potential for 
enhancing cadaver organ availability is in identifying potential ca- 
daver donors and appropriately requesting consideration of organ 
donation of family members. 

Mr. Chairman, I am attaching a copy of an executive summary 
of this survey to my testimony. I would like it to be published as 
part of my testimony. 

Mr. Gore. Without objection, we will include that in the record. 

Dr. Ogden. The key elements of a successful organ procurement 
and transplantation system include, first, surveillance by hospital 
personnel; second, potential donor identification by hospital and/or 
medical personnel; notification of the transplant coordinator; pre- 
liminary donor evaluation; pronouncement of death by the pa- 
tient's own physicians; informed consent of the next of kin ob- 
tained by the transplant team; the donor surgery; donor tests, in- 
cluding tissue typing; identification of potential recipients; trans- 
port of the donor organ to the recipient; final recipient tests; and 
finally recipient transplantation. 

The Gallup survey suggested enhanced organ donation can most 
likely be achieved by attention to surveillance by hospital person- 
nel, identification of potential donors, notification of the transplant 
coordinator, and appropriate request for informed consent from the 
next of kin. 

The remaining elements of the system I have described are large- 
ly in place and function more or less well in every large communi- 
ty in the Nation. 

Therefore, the National Kidney Foundation specifically recom- 
mends that the Joint Commission on Accreditation of Hospitals be 
asked to require that every JCAH approved hospital of 150 beds or 
more document the existing donor status from each patient's driv- 
er's license at the time of admission, recording this status on the 
admission form; that in the event of admission or transfer to any 
intensive care unit from the emergency room or any floor of those 
hospitals, the existing donor status be determined from the admis- 



234 

sion form and recorded on the ICU transfer form or intake form 
and in the initial intensive care unit nursing note. 

Compliance with these measures would be determined at the 
time of JCAH review and would be a factor in JCAH approval of 
the hospital's operation. 

We suggest that the American Medical Association and State 
medical societies be asked to encourage all physicians, through the 
chairman of the medical staff, to include in any "no code" or any 
"brain death" progress note a notation of potential suitability for 
organ donation and acknowledgement of existing donor status as it 
is recorded on the admission record; and that all physicians be en- 
couraged to notify the area transplant coordinator when in his or 
her professional judgment a dying patient may be a suitable trans- 
plant donor, whether or not the patient had previously indicated 
an intent to be an organ donor. 

We recommend that all appropriate medical and voluntary 
health agencies and the Department of Health and Human Serv- 
ices encourage all State legislatures to enact a uniform brain death 
law in those States that currently are without such legislation. 

Finally, that continuing medical education be encouraged by 
physicians and by professional and voluntary health organizations 
concerning the identification of potential donors, concerning organ 
donor procedures, and concerning the results of transplantation, 
and that these continuing medical education efforts be targeted 
particularly to intensive care unit nursing and physician person- 
nel, emergency room nursing and physician personnel and neurolo- 
gists and neurosurgeons. 

I would like to thank the members of this committee for your at- 
tention and for this opportunity to testify. 

Mr. Gore. Thank you. 

[The prepared statement of Dr. Ogden follows:] 



235 



April 14, 1983 

Testimony of David A. Ogden, M.D., F.A.C.P., 
President, National Kidney Foundation 



Mr. Chairman, Members of the Committee: 

My name is David A. Ogden, President of National Kidney Foundation, 
and Professor of Medicine at the University of Arizona College of Medicine. 
I appreciate the opportunity to speak to this committee on behalf of the 
many thousands of lay and multi-disciplinary professional volunteer members 
of the Foundation, which is the leading voluntary health organization 
dedicated to the needs of people witn kidney and urologic diseases. 

My comments will concern four subjects: 

1. The role of National Kidney Foundation in organ procurement; 

2. The present status, compared to the potential, of organ 
procurement ; 

3. The results of a recent Gallup Organization Survey ul" the 
"Attitudes and Opinions of the American Public Towards 
Kidney Donations"; 

4. Measures to enhance organ donation in the United States as 
suggested from the (Jallup Survey and by the Foundation 
membership. 

National Kidney Foundation Role : 

The National Kidney Foundation Organ Donor Program beg. m in 1968, 
witli support of the Uniform Anatomical Gift Act. Since then, the Foundation 
has printed and distributed over 30,000,000 donor cards, including 900,000 
cards distributed by means of a cooperative effort with the Lutheran Church, 



236 



in the September, 1982, issue of The Lutheran Witness , the official 
periodical of the Lutheran Church - Missouri Synod. The Foundation and 
its more than 50 Affiliates actively supported the individual State's 
driver's license organ donor check-off laws, which now provide for 
people in all 50 States to indicate their willingness to be an organ 
donor. The value of this option in enhancing public awareness of organ 
donation has been tremendous, as evidenced from the Gallup Survey. 

The Foundation conducts an active and ongoing program in support 
of kidney transplantation and organ donor publicity, through its own 
publications and through broader media. Recent efforts include arrangements 
by our Affiliates of numerous TV and radio appearances, and over 100 
newspaper articles describing Arnold Beher's "Gift of Life" 9000 mile, 
zig-zag, cross country bicycle tour with a bicycle "powered by a 
transplanted kidney"; Foundation support of the U. S. Team's participation 
in the 1982 IVth International Transplant Olympics held in Athens, 
Greece; creation, with the generous support of the American Contract 
Bridge League, of a dramatic film about kidney transplants titled 
"Bridging the Gap"; sponsorship of a one and a half day Science Writers 
Seminar in Washington concerned significantly with recent advances in 
organ transplantation, and resulting in many newspaper articles nationwide; 
and the just completed Organ Donor Blitz during which a number of members 
of Congress signed organ donor cards and the President met with NKF 
officials and endorsed the concept of organ donation. 



237 



The Foundation also met with representatives of IICKA, the liSKD 
Networks, and representatives of the Emergency Medical Services (EMS) 
Program to help establish a program to inform EMS staff of potential 
donor characteristics, and to foster a working relationship between 
EMS Coordinators and Regional Organ Retrieval teams. 

Present Status of Organ Procurement : 

The present status of organ procurement, based on 1981 figures 
(the last year for which accurate data is available), can be judged 
from the number of cadaver kidney transplants performed, compared to the 
number of kidneys potentially available and suitable for transplantation. 
In that year, there were 1,987,000 deaths in the U.S. from all causes, 
60% of which, or 1,192,000, occurred in locations potentially accessible 
for organ procurement. Only 1.5% of these people would meet existing 
criteria as potential organ donors for kidney transplantation. Thus, 
17,830 dead people might have contributed two kidneys each, providing 
35,760 kidneys (criteria for donation of hearts and livers are dissimilar 
to criteria for suitability for kidney donation, so it cannot be assumed 
that similar numbers might have donated a heart or liver). Of the 
35,760 kidneys potentially available, for various technical reasons, 
no more than 75% or 26,820 might be considered actually transplantable. 
An additional 10% wastage might be experienced in locating a suitable 
recipient. Thus 24,140 kidneys might have been potentially available 
for actual transplantation. In fact, 3,425 cadaver kidneys, or 14% of 
this number, were actually transplanted in 1981. 



238 



It is estimated that at any point in time, 6,000 to 8,000 U.S. 
dialysis patients are waiting for a cadaver kidney transplant. This 
number might change with the improving science of and results of cadaver 
transplantation, and might increase simply if cadaver organ availability 
increased, shortening the waiting time for some patients and increasing 
the probability of suitable tissue matching for hard-to-match patients. 

The Gallup Organization Survey : 

The National Kidney Foundation commissioned the Gallup Organization, 
Inc. to conduct a survey of "Attitudes and Opinions of the American 
Public Towards Kidney Donations" from January 14-22, 1983. Of a nationally 
representative survey sample of almost 1,600 persons age 18 and over, 
93% had heard of organ transplants, and 76% had heard of organ donor 
cards. Eighty-five (85%) percent of respondents were aware that kidneys 
were only sometimes or rarely available when needed. Thus, the American 
public is remarkably aware of the issue and the problem. We would like 
to think that this is reflective, in part, of the efforts of the National 
Kidney Foundation to educate the public in this area. 

Perhaps more remarkably, 83% of those aware of organ transplants 
indicated they were very or somewhat likely to donate the kidneys of a 
loved one, although only 40% were very or somewhat likely to want their 
own kidneys donated after death. Reasons most often cited for not wanting 
to donate their own kidneys after deatli were "I never really thought about 
it" (20%), and "I don't like the idea of someone cutting me up after 



239 



1 die" (20%). Of those very and somewhat likely to donate their own 
kidneys after death (40%), 31%, or 12.4% of the entire sample, had signed 
a donor card, and 41%, or 16% of the sample, had told their family 
members of their wishes. If the sample is truly representative of the 
U.S. adult population, then approximately 21-22 million adults have 
signed donor cards and 29 million adults have told their family members 
of their wishes to donate. 

A great deal more detailed information is contained in the 
Survey, an Executive Summary of which is available from the National 
Kidney Foundation, 2 Park Avenue, New York, NY 10016. However, from 
the information above, it is apparent that the shortcoming in organ 
availability is not a lack of public awareness or education, and it is 
not a lack of public willingness to grant permission for donation of 
organs after death. Indirectly, the Survey indicates that the greatest 
potential for enhancing cadaver organ availability is in identifying 
potential cadaver donors, and appropriately requesting consideration 
of organ donation of family members. 

Measures to Enhance Organ Donation : 

Typically, factors cited as inhibiting organ donation have 
included 1) lack of public awareness; 2) lack of public and professional 
education; 3) failure to philosophically recognize death as a natural 
part of life;. 4) the fact that 28 States do not have a "brain death" 
law; and 5) the lack of a nationally coordinated organ uonor network, 
including the logistic complexity of a nation,! 1 matching program. 



240 



The Gallup Survey suggests that although there is room for 
further public education, factors 1, 2, and 3 above are not major factors 
inhibiting organ donation. Certainly most medical professionals are at 
least as aware of organ donation as is the general public. Education 
of medical professionals concerning potential suitability of and recognition 
of suitable donors for various needed organs must be on-going. Passage 
of a brain death law by States not now having such a law would surely 
be of some benefit in increasing organ donation, but cadaver organs are 
currently obtained in States without brain death laws, and the absence 
of such a law has not been shown to greatly inhibit organ donation. 
Regional Organ Procurement Programs now exist in and cover virtually 
all regions of the country. Increasing telephone and computer links 
of these regional programs has produced a fledgling National Network. 
In any event, few organs are now wasted because of failure to identify 
a recipient. I am confident that, if the availability of organs 
increases, the organ sharing system will adapt and expand such that 
these organs will not be wasted. 

The key elements of a successful organ procurement and 
transplantation system include: 

A. Surveillance by Hospital Personnel 

B. Potential Donor Identification by Hospital and/or 
Medical Personnel 

C. Notification of Transplant Coordinator 

D. Donor Evaluation - Preliminary 



241 



E. Pronouncement of Death by Patient's Physicians 

F. Informed Consent of Next-of-Kin Obtained by Transplant Team 

G. Donor Surgery 

H. Donor Tests - Tissue Typing 

I. Identification of Recipient(s) 

J. Transport of Donor Organs 

K. Recipient Tests - Final 

L. Recipient Transplantation 

The Gallup Survey indicates that family members, if identified 
and asked, are likely to grant permission for organ donation. This 
suggests that enhanced organ donation can most likely be achieved by 
attention to surveillance by hospital personnel, identification of 
potential donors, notification of the Transplant Coordinator, and 
appropriate request for informed consent from the next-of-kin. The 
remaining elements of the system are largely in place and functioning 
well in every large community in the nation. 

Therefore, the National Kidney Foundation specifically recommends: 

1. That the JCAH be asked to require that: 

A. Every JCAH approved hospital of 150 beds or more document 
existing donor status from each patient's driver's license 
at the time of admission, recording this status on the 
admission form; and 

B. In the event of admission or transfer to any intensive 
care unit (ICU) from the emergency room or any floor 
of the above hospitals, existing donor status be 

ascertained from the admission form and recorded on the 
ICU transfer form (intake form) and in the initial ICU 
nursing note. 



242 



Compliance with these measures would be determined at the time 
of JCAH review and would be a factor in JCAH approval of the Hospital's 
operation. 

2. That the AMA and State Medical Societies be asked to: 

A. Encourage all physicians, through the Chairman of the 
Hospital's Medical Staff, to include in any "No Code" 
or "Brain Death" progress note, a notation of potential 
suitability for organ donation and acknowledgement of 
existing donor status as recorded on the admission 
record; and 

B. All physicians be encouraged, as in number 3 above, to 
notify the area Transplant Coordinator, when, in his or 
her professional judgement, a dying patient may be a 
suitable potential transplant donor, whether or not the 
patient had previously indicated an intent to be an organ 
donor. 

3. All appropriate medical and voluntary health agencies, and 
the Department of Health and Human Services encourage all 
State legislatures to enact the Uniform Brain Death Law in 
those States currently without such Legislation. 

4. Continuing medical education be encouraged by physicians, 
professional and voluntary health organizations concerning 
identification of potential donors, organ donor procedures, 

and results of transplantation, and be targeted particularly 
to ICU nursing and physician personnel, ER nursing and 
physician personnel, neurologists and neurosurgeons. 
I would like to thank the members of this committee for the 
opportunity to provide this testimony. 



243 

ATTITUDES AND OPINIONS -OF THE AMERICAN 
PU3LIC TOWARDS KIDNEY DONATION 

EXECUTIVE SUMMARY 



Prepared For: 
THE NATIONAL KIDNEY FOUNDATION 



Prepared By: 
THE GALLUP ORGANIZATION, INC. 

S3 Bank Street 
Princeton, New Jersey, CSS^O 



GO 8305 



February, 1383 



244 



BACKGROUND AtiD ML"T!!Ot>OLCrGY 

The National 'Kidney Foundation, as part of its plans for a national 
education campaign on the need for kidney donations for those needing 
kidney transplants, commissioned The Gallup Organization, Inc. to conduct 
i- survey of the American public en attitudes towards kidney donations. 

The survey was conducted by in-person interviews among a nationally 
representative sample of 1,57-', persons age 18 and over. Interviewing i:as 
conducted during January K through January 22, 1933. 



■y / r C'//x /? s '/' 



245 



T!O r .- IffiO ARfJiCRL l|m Y_T0 l.'AM T THE IK O'.n KIDNEYS D0NA1 EH f.riLl! HEATH AH! 

Those who are rr.ost likeky to want their own kidneys donated after their 
dc-:'th are those who have completed more foriii-il education and are in higher 
inccr.e brackets (tv;o interactive variables ). Blacks are rr-uch less, likely 
th;n whiter, to want their own kidneys donated (10" vs. 27:'). These sane 
demographic characteristics distinguish those rare likely to give permission 
for the kidneys of e loved one or their own child to be donated. 

f!A?:v RESPONDEN TS SAY THEY HAVE NEVE R REALLY THOU GHT ABpL'T IT HiQ ASKEIi TO 

~P./TI '.'/.PIOUS REASONS AS RE1N~G "VER'i IMP ORTANT " 

About one in five [20%) say that a \cry important reason for not wanting 
to have their kidneys donated after their death is that "I never really 
thought about it". 

DIS LIKE F0!i I DEA OF BE I NG CUT UP AFTER PEAT! I CITED AS "V EP.Y IMPO:-; JA! i T" KY 
ON E" IN FIVE " 

About the same proportion (20/:) cite as "very important", the reason 
"3 don't like the idea of somebody cutting rne up after I die". No other 
reason was cited by that large a proportion of respondents as being "very 
important": 

FF_V.' SAY T HAT R ELIGIOUS REASON'S OR COM P LICATED PERMI SSION PP.QCED'JSES AREJvTRY 
IMPCr.TANT 



r.z • 



Only 7" say either that the reasons "it is against :\y religion" or 
: "it is complicated to give permission" are \-Q\-y inp:-: '.r.nt reasons for 
wanting their own kidneys donated after their death. 






246 



'.--.! i':»: 'o ; ' iM" ir.rA or tsn.'Jr, cni up a_fjfr_natj!_ rs T!if reason which most 
sV:"£:HTl7i Yi iiiiTfiAjNFs" "Tiiosi" IroIiV "Am) lesVu :~:iy T6j^i_cr..-:| k; u^eys JWjJtfTn 

The greatest difference between those more and less likely to want their 
o;n kid;.c-vs donated is in their response to'- -the reason: "3 don't Tike the idea 

of sore'.o-.'y cutting me up after I die"'. Only l'. of these who say they are very/ 
scr-i'.-what likely to want their own kidneys donated characterized that reason 
as being "very important", compared with tt:l of those who arc not very/not at 
ell likely, more than twice the difference of each of the eight other reasons 
presented . 

FTV: HAVE TftSF^CJIQSS. TO LMPLEKEWT-JHlIR r;7£?ES7 IS MAV1MG TULU; QHH 

Less than half (41 '<) who say they are very/son:owr.et likely to want 
their own kidneys donated after their death have told family members about 
their desires. Even fewer (31'') have signed an organ doner card; told close 
friends (182); told a doctor (5S); or pot it in their will [£%). 

A'.;*?E:iE5S OF QR GA'f CONOR CARD S IS VERY_MIGK 

Seventy-six percent of those interviewed say they have heard of organ 

donor cards. Even among those net likely to want their own kidneys donated, 

76;: had heard of the cards; almost two-thirds of blacks interviewed (65*) 
had heard of them. 

A SMALL ?PGPCi. r aiCH_OF_J_h!_OSE A'. I ARE OF ORG Ai; LJl'h'QR CAP.DS KAVE SIGi.'ED TI'F-'-i 

Only 1C2 of those aware of organ donor cards have signed one. Ever, 
scong those likely to want their own kidneys donated, only 3f."-' have signed a 
card. 



.J/, &/fy fy,, ,;„/,<■,. ■_ Kr 



247 



*. 



r.osT coriRt ciiv as stss c c'.'slqu^cc.^of _s_i ciiujGjWj/.rMiqiiOK _c anus 

Virtual ly oil aware of organ tion'ii cards and virtually all who say they 
have signed an orgun donor cord bc-licvc correctly that tha f ol low! IK] two 

Statement s ore false: 

"If you signed a card, soricone can force you to give up one of 
your kidneys when they need one for a transplant." 

"Once you have signed a card, you cannot change your mind." 

VERY HI GH LEVE L OF PELIEF THAT A C ENTRAL FILE OF CARD S I GNERS^ JjO ST 

Almost two- tin" re's of those av?re of cards, and half of those who have 
signed cards believe, erroneously, that the following statement is true: 

"There is a central file of people who have signed donor cards 
which is made available to doctors or others who are. trying 
to locate a kidney donor." 

ABO UT OME- THIRD BELIEVE TH ER E ARE KIDNE Y BANKS . AS TH ERE ARE_ DLOOi ) t'.AflKS 

About one-third (31 r >) of those aware of organ transplants believe, 
erroneously, that there arc kidney banks, just as there are blood banks. 
This is equally true of those more or less likely to want to -have their own 
kidneys donated. Those who have signed an organ donor card are less lifcelv 
( 2 3 fi ) to believe this is true. 

VIRTUALLY NO O NE BEL IEVE S THAT DONATED KID NEYS ARE "ALVJAYS^ ^'AILAR-I E, 
"OFTE.'i" AVAIL ABLE, OR " NEVER" AVAILABLE 

Those respondents with an opinion split about equ:.lly between holicvino 
that donated kidneys are "sc::.e times" available (44:1) or "rarelv" available 
(415). 



z^kr S>C/'/yi C to.w;///;'-.- - . >^ 



248 



y-',- i.;-:o h\>: LEAST L 1_KELY_ TO W/WT_THl IJ! o.<:: hi eki;^ u:a:a;i j u _a;jj ;:_mu;: 
v'.';?' ;!;:[ iiu^Y"XjQ.-L L "l 1° " bL " ll " Lvt 1hiAT " Jl Ul : LLlL./jJ-k "haj'Lly" A'/aha^t '..t.e;: . 
AV r j>:j[ 

Those v-.-iio have signed on&aji donor cards ere more likely to say that 
kidneys ere "sometimes" available, rather than "rarely" available (4,7" to 39'.). 
This is true, as well, among those who are very/ somewhat likely to want their 
own kidneys donated (49r; say "sometimes" available; 38;. say "rarely" available). 

However, among those who say they are not very/not at all likely to 
want their own kidneys derated, only 36:': say that they think donated kidneys 
are "sometimes" available, with 46;' saying they are "rarely" available. 

•■'I-TU-u' Y :!0 C'! r SR.IEVE5 THA T KI DNEY TRAriSPLAi.'TSjlTHEFJ MAVEJ. ITT!_E 01: [:Q 

tffTtTh'^Wlx'CiPirrii's life, o~». that tliEY niGHT stic;:TLii ts at pl kson's life 

Even among these who say they are not very/not at all likely to want 
their own kidneys donated after their death, no wore than 1 or 2 percent 
chose either of these two responses as characterizing the effects of kidney 
donation on the person receiving a kidney transplant. 

'•.:V' L BH.1EVE THAT A KIDHEY TRANSPLAN T CAH "EXTEiiD THAT PtgSOri'S LIFE 

Tu.~ST7-1l7 lCLT~TTiA~;i TKAT ~IT "MIGHT fiff Ml" G: iT NOT EXTEND ft-'AT ? L','.i~)\:'' S LIFE" 

When presented with four possible effects of a kidney transplant on a 
recipient, about half "of all those surveyed who are aware of transplants 
chose the response: "can extend that person's life substantially", and 
another 42" chose the response "might or might not extend that person's 
1 i fe". 

As expected, more of those who signed an organ donor card (61"), an:! 
more" of those who are very/ somewhat likely to want their own kidneys donated 
(60 ) chose the response: ''can extend that person's life substantially". 

These who e^~e not very/not at all likely to want their own kidneys 
donated are significantly less likely than others to choose the response 
"can extend that person's life substantially" (40:'.), and significantly rr.orc 
li'-.ely than others to choose the response "might or might not extend that 
person's life" (46"). 



<rY C/Z/S 






249 

Mr. Gore. Our last witness on this panel is the executive director 
of the American Liver Foundation, Mrs. Thelma King Thiel. 

Mrs. Thiel, we are delighted to have us with us this morning. 

Mrs. Thiel. Thank you, Mr. Chairman, members of the commit- 
tee. 

I am the executive director of the American Liver Foundation, 
and I would like to mention that the American Liver Foundation 
has only been fully operational for about 3V2 years. Typically, the 
noncomplaining liver has been sadly neglected over the years. 

I am also the founder of the Dean Thiel Foundation, one of the 
first foundations in the country to focus on liver diseases, the 
fourth leading cause of death in our Nation. My son, Dean, in 
whose memory the foundation was named, would have been 17 
years old today. 

He was diagnosed at 2 weeks of age of having cirrhosis of the 
liver from biliary atresia. Each day of his 4 years on Earth I 
prayed for research to find an answer to save his life. I hoped and 
prayed, but my hope was transparent. Little was known and even 
less was shared with us as desperate parents. 

Today there is true substance to the word hope. The replacement 
of diseased organs is possible. Today we can roll away the stone of 
death and give new life to babies, children, mothers, and fathers 
with liver transplants. 

As the mother of a child who suffered the agonies of hell for 4Vfe 
years, I felt angry, cheated and crushed beyond belief to lose my 
precious son. Seventeen years ago a life-saving liver transplant was 
not within our grasp. Today the story is different, thank goodness. 
There is hope, miraculous hope. But with that hope comes the frus- 
trations and new problems. 

Liver transplants can save lives if a donor of the required age 
frame can be found and the liver retrieved quickly. Another if re- 
lates to the money. A new liver, a renewed life is attainable, if 
enough money is available to pay for this costly procedure. 

The American Liver Foundation receives calls daily from desper- 
ate individuals pleading for help. Where can they get the money to 
save their child s life? The only answer that we can give them is to 
contact your legislators, contact your insurance company, and go to 
the media. We are actually telling them to go out with a tin cup 
and try to pay for their child's liver transplant. I know how they 
feel. Our time ran out, but their clock is still ticking. 
_ In the 13 years since my son died, I have dedicated my life to 
finding the answers to liver diseases. I am proud to be working 
with the American Liver Foundation toward this end. We welcome 
this opportunity to share our concerns with you and to help find 
solutions for some of these agonizing problems. 

Over the years the lower level of funding for liver research has 
resulted in a severe lack of diagnostic tools to identify many of 
these insidious diseases until irreparable damage has been done. 

Effective treatments and cures are almost nonexistent for many 
of the 100 liver diseases that attack children, as well as adults. 
Most Americans know very little about their livers and how to pre- 
vent liver diseases. 

Liver transplantation, a last resort procedure just a few years 
ago, is the only hope for survival for thousands of Americans suf- 



250 

fering with incurable liver diseases. The cost of a liver transplant 
represents an investment in the restoration of a productive life for 
victims of liver disease. 

The need for more liver transplant centers and trained trans- 
plant surgeons is evident. The need for donors, a current problem, 
will increase dramatically in the next few months as several more 
transplant units are established. 

How can we possibly meet the demand for more donors? How 
can we stop the incredible waste of life-giving organs, lost daily 
through ignorance, indifference and perhaps fear? If physicians 
and other health care providers could only feel, for just one 
moment, the deep sense of anguish of a parent whose child s life is 
slipping away, they would not permit this tragic waste to occur. 

Unfortunately, they cannot walk in our shoes. Therefore, we 
must constantly remind them of the critical need for donors. They 
are on the front line. They are touching and feeling the pain of 
their patient and his family. They can help to ease that pain by 
suggesting that another life can go on through an irreplaceable gift 
that they alone can give. . . 

What greater gift can any of us give than one of life itself/ lhis 
giving of life may be, at the time, the only light in a sea of dark 
despair. One that can go on glowing for years to come, giving com- 
fort and solace to those who have suffered an irreplaceable loss. 

We must leave no stone unturned to seek out and retrieve all 
possible organs. The ALF would like to recommend the following 
actions: 

First. Heighten awareness of the public about the need lor organ 
donation through all possible media. Government and lay organiza- 
tions can work together in this effort. A clearinghouse could also 
help in this major role. 

Second. Provide donor cards on the reverse side of all drivers li- 
censes. Some states still need legislation to provide this service. We 
could encourage this through our driver education programs. 

Third. Inform physicians and nurses and allied health profession- 
als about the critical need for organs. Of course, the American Hos- 
pital Association, the American Medical Association, some of the 
lay and professional organizations could get involved in this area. 
Fourth. Establish criteria for recognizing brain death as death 
through each state department of health. 

Fifth. Establish a protocol for determining brain death in each 
hospital through the Joint Commission of Accreditation of Hospi- 
tals. This would be an appropriate medium for calling attention to 
the need for donors and for emphasizing the positive benefits and 
comfort families can derive from donating life-giving organs to vic- 
tims of incurable diseases. 

Sixth. Publicize in every health facility in the nation the hotline 
numbers for donor procurement and donor information. Every 
emergency room, intensive care unit and operating room should 
have prominent posters identifying these numbers, to save time. 
Time is critical, especially for the retrieval of livers. There is an 
extreme urgency to expedite the process. The Department of 
Health and Human Services could probably help in this effort. 

Seventh. Finally, costs must be controlled. We must continue to 
support the research to improve diagnosis, treatments and the 



251 

management of transplant patients while still supporting basic re- 
search to find cures. In particular, we must work to find reasonable 
answers to the cost of liver transplantation and support efforts to 
fund this therapeutic procedure. 

Thank you for calling us all together to help develop a plan for 
saving lives. The American Liver Foundation will continue to work 
to reduce the tremendous human suffering caused by liver diseases. 

[The prepared statement of Thelma King Thiel follows:] 



252 

- AMERICAN LIVER FOUNDATION 



TESTIMONY 
OF 
THELMA KING THIEL 
Vice Chairman and Executive Director 
American Liver Foundation 
Before 
The Subcommittee on Investigations and Oversight 
Committee on Science and Technology 

Chairman, Albert Gore, Jr. 
April 14, 1983 



253 

-AMERICAN LIVER FOUNDATION 



I am Thelma King Thiel, Executive Director and Vice Chairman of the American 
Liver Foundation, Vice Chairman of the National Digestive Diseases Advisory 
Board and an Advisor to the National Digestive Diseases Education and Infor- 
mation Clearinghouse. 

I am also the Founder of the Dean Thiel Foundation (DTF), the first health 
agency to focus attention on liver diseases, the 4th leading cause of death 
between ages 15-65. DTF is an affiliate of the American Liver Foundation. 

My son Dean, in whose memory the Foundation was named, would have been 17 years 
old today. He was diagnosed at two weeks of age as having cirrhosis from a 
liver disease called biliary atresia. Each day of his four years on earth, 
I prayed for research to find an answer to save his life. Research to me, at 
that time, was an illusion ... an undefined entity that might be able to 
create a miracle. I HOPED AND PRAYED . . . but my hope was very transparent. 
Little was known and even less was shared with us as desperate parents. 

Today there is true substance to the word HOPE. The replacement of diseases, 
almost petrified organs, is possible. Today we can roll away the stone of 
death and give new life to babies . . . children . . . mothers and fathers 
with liver transplants. 

As the mother of a child who suffered the agonies of Hell for four years, I 
felt ANGRY . . . CHEATED . . . CRUSHED beyond belief to lose my precious 
little boy. 17 years ago, a life saving liver transplant was not within our 
grasp . . . Today the story is different. There is HOPE . . . MIRACULOUS HOPE. 



254 

AMERICAN LIVER FOUNDATION 



But, with that hope come new frustrations . . . new problems. 
Liver transplants can save lives IF 

IF a donor in the required age frame can be found and the liver 

retrieved quickly. 

Another IF relates to money. 

A new liver ... a renewed life is attainable, IF enough money 
. is available to pay for this costly procedure. The American 

Liver Foundation receives calls daily from desperate individuals 

pleading for help. Where can they get the money to save their 

child's life? 

Frankly, ladies and gentlemen, I would have sold my soul if I 

had bad a chance to save my son's life. I know how they feel. 

Our time ran out . . . but their clock is still ticking. 

In the 13 years since Dean died, I have dedicated my life to finding the answers 
to liver diseases and am proud to be working with the American Liver Foundation 
toward this end. We welcome this opportunity to share our concerns with you 
and to help find solutions for some of these agonizing problems. 

Over the years the low level of funding for liver research has resulted in 

a severe lack of diagnostic tools to identify these insidious diseases until 

irreparable damage has occurred. Effective treatments and cures are almost 

non existent for many of the 100 liver diseases that attack children as well 

as adults. Most Americans know little about the liver and the prevention 

of liver diseases. Liver transplantation, a last resort procedure just a 

few years ago, is the only hope for survival for thousands of Americans suffer- 



255 



AMERICAN LIVER FOUNDATION 



ing with incurable liver diseases. The cost of a liver transplant represents 
an investment in the restoration of a productive life for victims of liver 
disease. The need for more liver transplant centers and trained transplant 
surgeons is evident. The need for donors, a current problem, will increase 
dramatically in the next few months as several more transplant units are 
established . 

How can we possibly meet the demand for more donors? 

How can we stop the incredible waste of "life giving" organs, lost daily 
through ignorance, indifference and perhaps fear? 

If physicians and other health care providers could only feel, for just 
one moment, the deep sense of anguish of a parent whose child's life is 
slipping away . . . they would not permit this tragic waste to occur. 

Unfortunately, they can not walk in our shoes. Therefore, we must constantly 
remind them of the critical need for donors. They are on the front line. 
They are touching and feeling the pain of their patient and his family. 
They can help to ease that pain by suggesting that another's life can go 
on through an irreplaceable gift that they alone can give. What greater 
gift can any of us give than one of life itself. This giving of life may 
be, at the time, the only light in a sea of dark despair . . . but one that 
can go on glowing for years to come . . . giving comfort and solace to those 
who have suffered an irreplaceable loss. 

We must leave no stone unturned to seek out and retrieve all possible organs 



256 



AMERICAN LIVER FOUNDATION 



every day. The list of recommended actions should be implemented as soon as 
poss ible . 

t. Heighten awareness of the public about the need for organ donation through 
all possible media. Government and lay organizations can work together 
in this effort. 

2. Provide donor cards on the reverse side of all drivers licenses. Some 
states still need legislation to provide this service. 

3. Inform physicians, nurses and allied health professionals about the 
critical need for organs. 

4. Establish criteria for recognizing brain death as death through each 
state department of health. 

5. Establish a protocol for determination of brain death in each hospital 
through a Joint Commission of Accreditation of Hospitals. This 
would be an appropriate medium for calling attention to the need for 
donors . . . and for emphasizing the positive benefits and comfort 
families can derive from donating life giving organs to victims of in- 
curable diseases. 

6. Publicize in every health facility in the nation the Hotline numbers 
for donor procurement and donor information. Every emergency room, 
intensive care unit, and operating room should have prominent posters 
identifying these numbers, to save time. Time is critical, especially 
for retrieval of livers. There is extreme urgency to expedite the 
process . 

7. And finally . . . costs must be controlled. We must continue to support 
research to improve diagnosis, treatments and management of transplant 



257 



AMERICAN LIVER FOUNDATION 



patients while still supporting basic research to find cures. In particu- 
lar, we must work to find reasonable answers to the cost of liver trans- 
plantation. 

Thank you for calling us all together to help develop a plan for saving lives. 



American Liver Foundation, Cedar Grove, NJ 07009 



258 



AMERICAN LIVER FOUNDATION 



YOUR LIVER - your most complex organ . . . yet the least understood 

Liver Diseases are the fourth leading cause of death in Americans between the 
ages of 15 and 65. Until 1976, however, no national organization existed to 
focus attention on the human suffering and economic burden resulting from liver 
diseases. The American Liver Foundation is acting as a catalyst to develop a 
national sense of urgency that will increase the research needed to have a sig- 
nificant impact on this sadly neglected health problem. Liver diseases are on 
the increase and represent a major health hazard. 

Liver diseases cause: 

o 50,000 deaths annually 

o $10 billion estimated economic cost 

o 1 million hospital admissions annually 
In addition: 

o 32,000 deaths a year due to cirrhosis 

o 8,000 deaths from cancer of the liver annually 

o 20 million Americans have gallstones 

o 500,000 gall bladder operations performed yearly 

o 500,000 to one million new cases of hepatitis each year 

Tragically, little has been done to address the increasing problem of liver dis- 
eases. Why? 

One problem is the lack of information about liver diseases among the general 
public. They are unaware that liver diseases have many causes including: 

o severe reaction to drugs (prescribed as well as over the counter) 

o several types of viruses 

o excessive use of alcohol 

o prolonged exposure to environmental chemicals 

o inherited and inborn abnormalities 

o parasitic conditions 

Patients often suffer from the stigma attached to liver diseases - a stigma based 
on the misconception that liver diseases affect only alcohol and drug abusers. 
Rather than endure this misunderstanding, patients conceal their illness, masking 
the magnitude of the problem. 

The low level of funding for research directed to liver and biliary tract dis- 
eases has caused progress to be slow in fighting liver diseases. 

More researchers and increased funding are needed to investigate liver problems. 

Many opportunities for advancing knowledge in liver function and disease are lost 

because the initial funds are insufficient and the potential for continued sup- 
port is uncertain. 

More liver specialists teaching in medical schools are needed to improve the 
quality of care provided by newly trained physicians. 



ALP, 998 Pompton Avenue, Cedar Grove, NJ 07009 



259 



AMERICAN LIVER FOUNDATION 



American Liver Foundation Research Programs 

An increased investment in liver research is essential to discovering cures and 
treatments that will lessen the human suffering and economic burden that liver 
diseases inflict on us all. The American Liver Foundation gives researchers the 
opportunity to select and remain in liver research by funding the following 
programs: 

o Student Research Fellowship awards for medical and doctoral students to 

stimulate their interest in liver research at a time when they are making 

career choices, 
o Postdoctoral Research Fellowship awards of $7500 which supplement N.I.H. 

fellowship grants to provide a living wage for young researchers. 

Education of Health Professionals ' 

The Foundation sponsors continuing medical education courses for physicians and 
other health professionals on the important advances that have occurred in the 
diagnosis, pathology and treatment of liver diseases - an important means of im- 
proving patient care. 




Pediatric Liver Council 

The American Liver Foundation has developed the Pediatric Liver Council to ad- 
dress particular needs in the area of children's liver diseases for research, 
education, training of health professionals and family support. By publishing a 
newsletter, SHARING CARES AND HOPES, the Pediatric Liver Council provides a means 
for families to share their concerns and give support to one another. 

Coordination of a National Effort Through Chapters 

For those afflicted with liver disease, a sense of hope is essential: To meet 
this need, the American Liver Foundation is organizing and coordinating mutual 
help groups through its Chapters to provide emotional support for patients and 
their families, make referrals to specialists when appropriate, and keep people 
abreast of the latest research developments through special programs such as 
"Meet the Researchers." These Chapters are assisting in educating the local com- 
munity and increasing awareness of the need for more research as well as pro- 
viding grass root support for all national programs. 

How is the American Liver Foundation Funded ? 

As a non-profit, tax-exempt, national health agency, the American Liver Founda- 
tion receives funds directly from the general public and through its Chapters in 
the form of memberships, memorials, bequests and from special fund raising 
events. In addition, the American Liver Foundation is the recipient of grants 
from corporate and private foundations. 

ALF, 998 Pompton Avenue, Cedar Grove, NJ 07009 



260 




SHARING cares and hopes SHARING cares and ho/> 



AMERICAN LIVER FOUNDATION 

PEDIATRIC LIVER COUNCIL 

998 Pompton Avenue, Cedar Grove. N.J. 07009 



Winter 1983 



Sharing concerns with others who are experiencing similar problems builds 
a special bond of friendship and understanding. It helps to provide the 
strength and courage to face the uncertainty of the days ahead. Many 
heavy burdens of care have been lightened by sharing joys and heartaches 
with those who understand. 

We are pleased to publish another issue of Sharing Cares and Hopes and 
invite you to call or write us to add your name to our list of thoughtful 
and concerned friends. 



"A GRANDPA'S LOVE" 



C/) 

I 

1 

2J 

u 

o 

z 

s 

< 



My little Anneliese 

How I have loved you from the start 

Sharing with me your quaint little ways 

You have stolen your Grandpa's heart 

I have watched you touch both young and old 

Cloaked in courage for all to behold 

With innocence of child you have questioned not 

As you have walked through the valley of doubt 

Unselfish in love, undaunted in faith 

A child's teaching of what life's all about 

0' my precious little Annie 

You symbolize what our Lord means life to be 

When he spoke "Suffer the little children to 

come unto me" 

May I always be humble, even in moments of grief 

and dispair 

To know I was among those chosen in your 

precious little life to share 

And should the Lord send forth His angels 

That we must bow to His command 

I shall keep the child's faith you taught me 

To know such things are wisely planned. 



Our 7 year old daughter Anneliese has Biliary Atresia. She is jaundiced, 
has an extended stomach, terrible itching and Cirrhosis which has caused 
her to have 2 episodes of internal bleeding. We are pleased to share 
this poem that was written for our daughter by her grandpa. 



Eugene and Jerri Kedziorski 
4248 A Street, S.E., #425 
Auburn, WA 98002 
206-939-9697 



d ctoq pue saieD OMIHVHS sadoq pue saaeD OMIMVHS sa< *° 



261 



November 27, 1978 will always be a special 
day in my life. On that day I lost my four 
year old dauahter, Seth, to a disease known 
as Biliary Atresia. It hurt and it proba- 
bly always will. A part of my heart be- 
longs to her and even though I have two 
other children, 7 and 2 years of age, no 
one will ever take her place. We were 
waiting for a liver transplant for Beth 
when she died. I was furious because they 
weren't able to find a liver for my daugh- 
ter. I finally came to terms with these 
feelinqs and decided that I had had Geth 
for four and a half wonderful years. I 
qave my dauqhter everything I had to give 
and more. She touched all our lives in a 
very special way. She enriched my life and 
showed me, that no matter how badly losing 
her hurt, life goes on. If there's anyone 
else who's been through the same pain as I 
have, please write or call. It would help 
to know I 'm not alone. 

Nancy Coppolino 

7 Elm Street 

So. Barre, MA 01074 

617-355-274? 



Rachel Joy had a Kasai operation for her 
Biliary Atresia when she was 3 months old. 
She's a very happy little girl now at 13 
months of age. She has a problem with 
fluid retention and Cirrhosis, although her 
bilirubin count has been steadily drop- 
ping. She is on a low sodium diet and 
Portagen - loves puffed wheat; We know 
that she's the Lord's, but are praying that 
someday she will be able to receive a suc- 
cessful liver transplant. We also have a 5 
year old daughter, Julia, who is very lov- 
ing and understanding. We are very thank- 
ful for our Chapter and Christian friends 
and family who are so helpful to us. 

John and Carol Van Walbeek 
2326 Springbrook Drive, N.E. 
Cedar Rapids, IA 52401 
1-319-393-5562 



My son Scott is eight years old and in the 
second grade. He was diagnosed with Alpha 
1 Antitrypsin when he was a baby. I be- 
lieve in the quality of life and strive to 
help Scott to lead as normal a life as pos- 
sible. Talking to other parents in similar 
situations has been helpful. Only through 
sharing thoughts, experiences and feelings 
can we grow and learn to make life for us 
and our children the best it can be. I 
would love to share with other parents of 
children with liver diseases. 

Linda Bramble 

3207 Highland Boulevard 

Highland, MI 48031 

313-887-2954 

Pamela was born 5 1/2 years ago with Bili- 
ary Atresia. After 3 Kasai Procedures and 
several additional hospitalizations, Pamela 
now functions as a normal kindergartener. 
She plays the piano, goes to dancing school 
and even attends summer camp. She is our 
miracle and our joy and we cherish each day 
that we share with her. We know that Pam 
has Cirrhosis and a bilirubin which contin- 
ues to climb. We live with the hope that 
either a medical breakthrough or transplant 
will allow her to live a long and normal 
life. In 1981, I initiated efforts with my 
N.J. Congressman, Senator and ALF to meet 
with Surgeon General Koop and others to ex- 
press our concerns about the role which the 
Federal government might assume in liver 
transplant research, support for the finan- 
cially burdened families of patients and 
the reclassification of transplantation 
from "experimental" to "therapeutic." Sub- 
sequent meetings were held and this June a 
large Consensus Conference open to the pub- 
lic, will take place in Washington to ex- 
plore the entire issue of liver transplan- 
tation. I have found that working toward a 
goal both with the Foundation and my local 
and Federal officials has helped channel my 
energy and initiative in a positive dir- 
ection. Much more needs to be done and I 
welcome the opportunity to talk to others 
with a similar perspective. 

Gail and Jeff Rempell 
41 E. Cheryl Road 
Pine Brook, NJ 07058 
201-575-3654 



262 



Little Emily Heiple jogs around the dining 
room table, loves dressing up in her moth- 
er's clothes, and attends Kindergarten. 
She has a contagious smile which she loves 
to flash when she's in trouble for writing 
on the walls. She has one natural sister 
and an adopted brother and sister. She's 
the least disciplined of the 4 which can be 
explained by her spending most of her first 
2 years of life in Rochester, Minnesota un- 
dergoing 4 operations for Biliary Atresia. 
Emily is fast approaching her 6th birthday 
in spite of elevated liver function tests. 
She remains non-jaundiced but has Cirrhosis 
and portal hypertension. Her energy level 
far surpasses the rest of the family. She 
usually wears everyone down while leaving a 
trail of messy rooms behind as evidence. 
It is difficult to think about the future 
and what that means for Emily and our fam- 
ily. We are interested in sharing with 
other families how we have learned to live 
one day at a time and enjoy it. 

Rita and Joe Heiple 
111 Graceline Boulevard 
Waterloo, IA 50701 
319-235-6986 



Our Sara, age 3, appears to be as normal 
and active a child as any in La Porte, In- 
diana. Certainly her three surgeries and 
11 hospitalizations are not apparent in her 
snappy brown eyes and bouncy walk. Sara 
has Biliary Atresia, but has responded to 
surgical revision to drain bile. Sara is 
one of a group of children treated at Riley 
Hospital in Indianapolis, who are non-jaun- 
diced and growing well after successful 
Kasai Procedures. A biopsy late last sum- 
mer indicated Sara's liver is functioning 
well and incurring no new Cirrhosis. Sara 
frequently talks about her painful experi- 
ences. Even her dolls all have I.V. shots, 
medicines, etc. We are so grateful that 
the real tragedy of chronic liver disease 
has not been her fate. The wasting away, 
swollen belly, lack of lustre and energy 
are not part of Sara's exuberant life. 



Randy and Nancy McGriff 
108 Lawrence Street 
La Porte, IN 46350 
219-362-7395 



Our daughter, Michele, was diagnosed as 
having Chronic Active Hepatitis at age 8. 
She developed a secondary immune-complex 
disease after beginning medication. She 
experienced a number of side-effects from 
Prednisone the first year of her illness. 
Michele is now 12 and currently taj<es Pred- 
nisone and Imuran. She has not developed 
Cirrhosis and has almost full liver func- 
tion. She is active in SDorts and only has 
occasional problems from her illness. We 
would be happy to communicate with other 
Chronic Active Hepatitis patients. 

Stan and Janice Lange 
2024 North Street 
San Angelo, TX 76901 
915-949-0244 



Our son, Alex, now six years old, was born 
with a genetic enzyme deficiency of the 
liver, Alpha 1 Antitrypsin Deficiency. 
This deficiency was diagnosed at birth, be- 
cause of prolonged jaundice and other prob- 
lems. So far, our prayers have been an- 
swered, and he is our miracle boy, since 
his liver appears to be functioning ade- 
quately. However, we continue to pray that 
an effective long-term treatment can be 
found. Our newest addition, another little, 
boy, was born perfectly healthy. We beat 
the odds! 

Mrs. G. Bertram Wells 
3112 Old Crow Court 
Lexington, KY 40502 
606-266-0379 



Our daughter, Susie, was born June 16, 
1978. She seemed to be a happy and healthy 
baby but became jaundiced at one month. 
After two biopsy's she was diagnosed as 
having Byler's Disease, a hereditary dis- 
ease of the liver. She is now 4 1/2, is 
jaundiced and itches constantly. She is 
behind most children her age and has a 
hearing problem due to frequent ear infec- 
tions. Our only hope for this very special 
child God has given us would be a liver 
transplant one day. We would like to write 
to others to share our special concerns. 

Owen and Clara Mi 1 ler 
R #3 16020 Nash Road 
Middlefield, OH 44062 



263 



Our beautiful 26 month old daughter Summer 
was diaqnosed at 2 months as having Biliary 
Atresia. Her Kasai was done at that time 
with a biliostomy. She had a fair amount 
of drainaqe and it was reconnected when she 
was 21 months old. Her condition is stable 
but her Cirrhosis is considerably advanced. 
When she was 2 she was examined in Pitts- 
burgh for a transplant but nothing will be 
done unless she gets worse. This uncer- 
tainty is murderous! We are starting a 
Chapter of ALF in Houston. We would love 
to talk to anyone concerning liver disease. 

Debbie and Tommy Martin 
1506 Sue Barnett 
Houston, TX 77018 
713-686-1770 



Lauren was diagnosed at 13 months with 
hereditary Tyrosinemia. The prognosis was 
grim. We spent a long time trying to deal 
with that tragic sentence. Our lives and 
values changed dramatically. Our family, 
friends, and even some doctors had never 
heard of Tyrosinemia. We wanted to talk 
with other families with Tyrosinemia but 
none of our medical contacts were able to 
help. A year later, through a friend, I 
heard of the American Liver Foundation. I 
called Thelma Thiel, Executive Director of 
the Foundation, who knew of another family 
with a similar problem and we were able to 
talk to them. At 2 1/2 cancer was diag- 
nosed in Lauren's liver, and she was given 
3 to 6 months to live. The idea for a 
liver transplant came from "Sharing Cares 
and Hopes." I called Thelma for her input, 
and she gave me Dr. Thomas Starzl's phone 
number. Five days later we were in Pitts- 
burgh for transplant evaluation. After 
much public appeal and the enormous gener- 
osity of many people, Lauren had transplant 
surgery in November '81. She looks great, 
has enormous energy, and loves nursery 
school. The American Liver Foundation 
played a vital role in saving Lauren's life. 

Beatrice and Joseph Toohey 
12 McKinley Drive 
Kinnelon, NJ 07405 
201-492-0920 



Our daughter, Alesha, died Christmas Day 
1982. In April, at 2 months, she had been 
diagnosed as having Biliary Atresia. The 
Kasai Procedure was done although no major 
bile ducts were found. Two days after she 
left the hospital bile began to flow. 
Alesha was stable until October when a 
serious infection set in. A call to the 
American Liver Foundation brought us infor- 
mation and much needed support from 
Veronica Otterberg of ALF's Omaha, Nebraska 
Chapter. Her condition worsened in Novem- 
ber and we realized that a transplant was 
only life saving option and found that the 
cost was very high and at this time she was 
too small to have the surgery. We decided 
to set up a trust account and began to 
raise funds to defray the cost of a liver 
transplant. Having spent a week in the 
hospital before Christmas, Alesha 's condi- 
tion had stabilized enough for us to take 
her home Christmas eve. She was alert and 
we had a wonderful loving time with the 
whole family. That night our little dar- 
ling died peacefully in my arms. We are 
grateful for the thoughtfulness and concern 
we received from our dear friend Veronica 
and the ALF. We thank them for their work 
in education, research and providing mutual 
support for parents and families. We would 
be willing to share the concerns of others. 

Glenda and Vince Mahaney 

Route 4 

Denison, IA 51442 

712-263-6686 



Micki is planning to go to College in the 
fall. At 17, her Chronic Active Hepatitis 
with Cirrhosis is in remission and she is 
involved in many extra curricular activi- 
ties at school and has a part time job. 
Micki recently did a term paper on liver 
transplants and is extremely interested in 
new advances in research. We have made 
some marvelous friends and are coping much 
better with Micki ' s Hepatitis. We'd like 
to help others the way we've been helped 
through sharing our concerns with others. 

Marie Mendl 

117 Arbor Vitae R4 

Metamora, 1L 61548 

309-383-4665 



264 



AFFILIATES 

Dean Thiel Foundation 
Thelma King Thiel 
30 Sunrise Terrace 
Cedar Grove, NJ 07009 
201-857-2626 

Pediatric Liver Research Foundation 

Phi 1 ip Aristone 

Route 206 

Tabernacle Road 

Indian Mills, NJ 08088 

609-268-2074 



CHARTERED CHAPTERS 

Michael and Laura Pagel 
810 Wildwood Court 
Streamwood, IL 60103 
312-837-9102 

Randy and Nancy McGriff 
108 Lawrence Street 
La Porte, IN 46350 
219-362-7395 

Elizabeth A. Mullendore 
680 Woodale Terrace, Apt. 2 
Greenwood, IN 46142 
317-881-4768 



Dick Vallin 

700 Jamestown Road 

Auburn Heights, MI 

313-333-0356 



48057 



Tom and Michele Sherrill-Mix 
427 Saginaw Street 
Alpena, MI 49707 
517-356-9265 

Carmela Colucci 
154 Rumsey Road 
Buffalo, NY 14209 
716-886-0084 



Sheila Ivrin 

87 Ashland Drive 

Kings Park, LI, NY 11754 

516-265-3878 

Anthony Shee 

123 Red Bud Drive 

Beaver Falls, PA 15010 

412-847-3504 

Richard Norgaard, M.D. 
Barnett Tower 
3600 Gaston Avenue 
Dallas, TX 75235 
214-824-3212 

Peggy Cathy 

4808 N.E. 41st Street 

Seattle, WA 98105 

206-525-0180 



CHAPTERS-IN-FORMATION 

Dorothy Simms 
1064 Celestial Way 
Yuba City, CA 95991 
916-673-4584 

Ken Donahue 

245 S. Westgate Avenue 

Los Angeles, CA 90049 

213-476-2304 

Brenna Dean 

5501 Trent Court, #110 

Alexandria, VA 22311 

703-379-3959 

Joyce Ferrante 

9120 Fontainbleau Blvd. 

Miami, FL 33172 

305-223-1959 



#401 



265 



CHAPTERS-IN 


-FORMATION 


Joyce Ferrante 


Kate Collins 


9120 Fontainbleaj Boulevard, #401 


2250 Connell Terrace 


Miami, FL 33172 


Baldwinsville, NY 13027 


305-223-1959 


315-635-5141 


Rita Heiple 


Mattie Lee Mil ler 


111 Graceline Boulevard 


818 Colonial Drive 


Waterloo, IA 50701 


Burlington, NC 27215 


319-235-6986 


919-584-6958 


Bonnie Cubbage 


Tom Davey 


3938 Brooklyn Avenue 


643 Genenbi 1 1 Drive 


Baltimore, MD 21225 


Cincinnati, OH 45238 


301-355-2402 


513-451-3475 


Peter McCue 


Bonnie Schmidt 


160 Commonwealth Avenue, #218 


27413 Detroit Road 


Boston, MA 02116 


Apt. G-32 


617-536-7151 


Westlake, OH 44145 




216-835-0112 


Walne Casanova 




P.O. Box 552 


Dorothy Mandelbaum 


Picayune, MS 39466 


2290 N. 53rd Street 


601-798-4518 


Philadelphia, PA 19131 




215-877-2856 


Veronica Otterberg 




6915 Evans Street 


Debbie Martin 


Omaha, NE 68104 


1506 Sue Barnett 


402-571-5417 


Houston, TX 77018 




713-686-1770 


Cynthia Gales 




17 South Portland Avenue 


Mary Ann Armijo 


Brooklyn, NY 11217 


2507 Summitview 


212-522-2762 


Yakima, WA 98902 




509-575-6521 




American Liver Foundation 

30 Sunriie Terrace, Cedar Grove, N.| 07009 



BULK RATE 

U S POSTAGE 

PAIO 

PERMIT 59 
NONPROFIT 



266 

Mr. Gore. Thank you, Mrs. Thiel. 

We will now have questions for the panel. 

We have two beneficiaries of transplants on this panel. There are 
so many others who are awaiting transplants. The subcommittee 
has been literally flooded with letters from parents from around 
the country. Some of them have been provided by you, Mr. Fiske, 
and we have been flooded with pictures of beautiful children who 
are waiting for transplants. Clearly we need a national strategy to 
solve this problem. 

In addition to research and development, it seems to me there 
are three issues, in ascending order of importance. The first is a 
better organization for organ procurement; second, the removal of 
the funding obstacles that so many families have to hurdle; third, 
and most important of all, the raising of the awareness in this 
country of how important organ donation is. 

We could solve most of this problem if families across this coun- 
try had a conversation over the dinner table or at the breakfast 
table and said to each other, as a family we think that organ dona- 
tion is a good idea, that we hope no tragedy ever occurs in our 
family, but if one dies, at least it could lead to hope and joy for 
some person who might not live without an organ transplant. 

Mr. Fiske, I want to ask you a question about that issue first. 

What would you say to a family that was having a conversation 
around their dinner table and somebody in the family spoke up 
and said, "Well, I just don't think that organ donation is a good 
idea. I am a little nervous about it. I don't like to think about it. I 
don't like to think about dying. I don't like to think about an organ 
being removed after death." What would you tell that person? 

Mr. Fiske. I think, Mr. Chairman, you have probably hit the nail 
on the head by saying that it is families themselves, talking like 
that informally, where the change really does take place. 

I think my first response to anybody like that, the fact that it is 
even talked about is encouraging. The fact that somebody says no, I 
don't think it is a good idea, they are raising the issue within the 
family. I think that is probably very encouraging. If that takes 
places, then it is a very optimistic sign. 

I think what I would suggest to any family where that does come 
up is to keep talking about it. To cram that idea down somebody's 
throat, to force them into it is not the way to go. 

I think probably the clearest example of that in our case was the 
Bellon family, having two children, at 5:30 at night, happening to 
have the TV on and making that decision subconsciously at that 
point. The following Tuesday they had done it. I think it has to be 
a free kind of choice and it has to be an ultimate gift kind of 
choice. 

I would suggest to family members, if there is that kind of resist- 
ance, what are the obstacles to that. What is the reason for not 
doing that, and respecting that kind of decision because I think 
that really has to remain there, that each individual does have 
that choice to say I don't think it is a good idea. 

I think it is healthy to keep bringing that up. I guess that is 
what I would recommend, is to continue talking about it. 

It is easier to talk about it around particular cases. You are talk- 
ing about two very difficult situations. On the one hand, the donor 



267 

person who is going to be declared brain dead, and the other 
person who will die by not having a transplant. They are both very 
difficult concepts to handle. 

It becomes a bit more understandable around individual cases. 
Michele is probably a good example right here because she has had 
the benefit of that kind of giving. Jamie is a good example. 

The whole issue of transplantation across the board is a hard one 
to understand. If you take a look at Jamie, with Jamie right now, 
there are two other children that I have seen. I don't think I have 
ever met them, but I would say that both of those children have 
some form of end-stage liver disease that probably will need a 
transplant at some point. 

I think when people see these two children side by side, to say 
Jamie was where these children are, that is a good thing to do. 
Even though it may be difficult to talk about dying, it may be diffi- 
cult about talking about those issues, Jamie directly benefited from 
the Bellon family in Utah taking the time to give that gift of life. 

If it is made very concrete, and if that is done over a period of 
time and people discuss it, then it doesn't become so conceptual. It 
becomes something that a family can say take a look at Jamie, 
here she is, as the pictures demonstrate the before and the after. 
There is a marked difference. 

I guess that is what I would suggest. 

Mr. Gore. I think that is a very effective way to do it. I hesitate 
to ask this of any of the families who have come here, but do you 
care to say something? If you care to speak to the subcommittee — I 
know this is unusual and I will ask my colleagues' indulgence — Dr. 
Ogden, if you could let her take your seat briefly, we could take 
Mr. Fiske's advice and just paint the issue in as stark terms as pos- 
sible. 

Your name, ma'am, is? 

Mrs. Goode. Virginia Goode. I am from Morningside, Md. This is 
Nicky. 

Mr. Gore. You live in the area? 

Mrs. Goode. Yes. 

Mr. Gore. And your child's name? 

Mrs. Goode. Nicholas Goode. He is 22 months old. He has biliary 
atresia. He has been waiting for 5Vz months for a donor. 

Mr. Gore. He has the same condition that Jamie Fiske, right 
behind him, had? 

Mrs. Goode. As does the little girl over here, who is 13 months 
old. She is Candy Thomas. 

Mr. Gore. How old is your child? 

Mrs. Thomas. One year old. 

Mr. Gore. And the name of the child? 

Mrs. Thomas. Candice. 

Mr. Gore. Candice Thomas is the child's name. 

In other words, the point you were trying to get across, Mr. 
Fiske, is much more clearly illustrated by the difference between 
these two children. 

Mr. Fiske. I think it is a gift of life situation, where you are talk- 
ing about the opportunity of giving life to somebody else through 
some kind of generous thinking about it. With our situation, the 



268 

Bellon family, in the midst of the death of their son, Jess, thought 
about life for Jamie. . 

So you have two contrasting kinds of ideas: the one issue of 
dying, but also in the process of that, extending and giving life to 
somebody who desperately needs that particular organ. Jamie is a 
good example of receiving a gift of life in the midst of a death situ- 
ation with the Bellon family. 

Mr. Gore. Mrs. Goode, you are still waiting for an organ to be 
donated for your child, is that correct? 
Mrs. Goode. Yes, sir. . 

Mr. Gore. Mrs. Thomas, you are still waiting for an organ to be 
donated for your child, too? 
Mrs. Thomas. Yes. 
Mr. Gore. Biliary atresia, also? 
Mrs. Thomas. Yes. 

Mr. Gore. And you are from the local area, also? 
Mrs. Thomas. Accokeek, Md. 

Mr. Gore. Thank you very much. I appreciate that very much. 
Mr. Fiske, I have one other question and then I want to turn to 
my colleagues. 

On the question of funding, I think it is very important to note 
that if someone in your situation, in your home town, went back to 
the same Blue Cross-Blue Shield company and asked for funding of 
a liver transplant, they would be likely to be turned down. Isn t 
that correct? 

Mr. Fiske. To answer very clearly what they said to me in writ- 
ing, "Due to the extenuating circumstances in this particular case, 
we have made an exception." 

Mr. Gore. In other words, because of what they regarded as a 
mistake and then because of the enormous amount of national pub- 
licity, they made an exception in your case. But there are other 
cases where families need a liver to be transplanted to save the life 
of their child, where the same company will refuse to pay for it. 
Mr. Fiske. The other thing I think that should be mentioned is 
that liver transplants are not the way to go to treat liver disease. If 
I can put that in context, Jamie had an extremely difficult situa- 
tion with biliary atresia. Other procedures were tried ahead of 
time. She had an 8-hour operation in February, and a 4-hour oper- 
ation in July. The last treatment of choice was a liver transplant. 
If we didn't have to go through that, we would not have. We had 
no other choices at that particular point in time. 

What was happening, too, is the sicker that Jamie got the higher 
the medical costs got. If you take a look at her hospital bills from 
July 6 through the date of transplant, they increase markedly be- 
cause she was declining at a rapid rate. After that, they reached a 
peak with the transplant and then declined. 

On December 16 she left, and the only hospital bill that we have 
had facing us from Blue Cross-Blue Shield is that 2- to 3-day 
checkup in Minnesota, which was to see how she was doing. It is 
somewhat cost effective to have given her the liver transplant. 

Mr. Gore. It is a good point. We certainly hope that we can 
change the financing policies of the Federal Government and the 
private insurance companies to save lives and, as you point out, to 
save money, too. It is ironic that it would do both at the same time. 



269 

Congressman Skeen? 

Mr. Skeen. Thank you, Mr. Chairman. 

I would like to comment on how traumatic I am sure it is for 
those of us who have never been touched by this kind of a problem 
to say well, this evening we are going to read the Bible and right 
after that we are going to have a discussion about being an organ 
donor. 

That probably ought to be a good procedure in a family, if they 
only knew how important this discussion might be. I think it was 
pointed out in the testimony that the media has played an ex- 
tremely important part. 

We are fond, in the great halls of this body, of castigating the 
media time after time for some of the things that they don't do, but 
very seldom do we ever give them credit for some of the good 
things that they do. I know that it creates some problems, too, inso- 
far as ethics about whether the media influences, gives someone an 
advantage and so on. However, they have done an outstanding job 
in this area, as has been pointed out in both cases today, I know in 
Michele's. 

It is very difficult for people to overcome a natural repugnance 
at the idea of talking about donating organs. It is something that 
we need as a society to learn to do, is to get over the idea that 
there is something wrong or bad about talking about leaving parts 
of ourselves. 

There is only one way besides procreation on this earth that you 
can extend life, and now we have the technology to do that. It is 
another form. I think you said it very well, Mr. Fiske, that this is a 
new way to give life. The technology involved in the medical world, 
the pharmaceutical world, and so forth is a great gift and one we 
should take advantage of. 

I want to ask Michele a question because I know that in our own 
family circle — Michele, you did an outstanding job. You weren't 
nervous at all during your testimony; I told you it would be OK. 

I know that Michele had a question in her mind. This young lady 
has had to take the brunt of making those decisions, where the 
family could help only to a certain degree. Mr. Fiske had a differ- 
ent type of a problem. Mr. and Mrs. Fiske had to make the deci- 
sions for their child. But one of the difficult decisions that Michele 
had to make was whether or not to go family donor or to go ahead 
and consent to a cadaver donor. 

Michele, I would like to know, how did you finally change your 
mind? I know for some time you had decided that you would only 
accept an organ from some member of the family. I know it was a 
tough decision for you, but it changed the whole outlook on your 
problem. How did you finally make that decision? Was it tough? 

Ms. Jones. Well, when I started I was going to go living-related. I 
had five family members to choose from. Through the tissue typing 
they had decided my sister was the best choice. She was a perfect 
four match. But she said no because she had two small children 
that she was worried about, who may develop kidney problems 
sometime that she might want to donate to. 

The other four members were a two match. My one brother had 
said he would like me to go cadaver first. He was a law student, 



270 

and he was starting his last year of school and wanted to get into 
practice. 

It had gotten down to the three other members, my mom, my 
father, and my other brother. They sat there and bounced it back 
and forth between the three of them on who had lived the best so 
far, like I have lived the longest, I have lived a full, happy life. If 
something should happen to me on the table, then we have nothing 
to complain about. My brother would say no, I should, we need to 
have the parents around. 

They went back and forth with this so much and they would not 
let me decide. It was something that I couldn't decide for them. Fi- 
nally, I think I got so fed up with them not making a decision, not 
deciding, that I decided cadaver, that was the way I was going to 

I also released the pressure from them. I was releasing pressure 
from other family members outside of the immediate family, like 
my aunts, because they had worried about my father donating be- 
cause there had been kidney problems on both sides of the family 
on my dad's side. My mom had had kidney stones, which wasn't 
really related to what I had. Finally I said that's it, I am going ca- 
daver. I did get the transplant. 

Mr. Skeen. I think it is an important element in this discussion 
because here again is a situation created where everyone wants to 
help, but within a family it can cause such an aura of tension, so 
you have to learn to deal with this kind of a problem as well. 

I think it is far easier to discuss among the family the possibility 
before an acute problem occurs. I think every family ought to do 
this and should they be asked, be ready to make the decision that 
at your death you want to donate organs. Otherwise the alterna- 
tives that this young lady had were extremely difficult and almost 
caused an alienation within the family. 

That is just another one of the things that is happening. I think 
it is extremely important. 

I would like her to elaborate on the financing. Michele, how are 
you financing your operation? 

Ms. Jones. When I first started on dialysis, we tried to go 
through Blue Cross-Blue Shield. It took much, much help from you 
and from several others to get Blue Cross-Blue Shield going and 
start making payments. As soon as we got medicare stepping in 
and taking over 80 percent, Blue Cross-Blue Shield has kind of 
backed out of the picture. That is one thing I would like to say 
about it. 

Mr. Gore. Will my colleague yield? 

Mr. Skeen. Certainly. 

Mr. Gore. One of the problems that the liver patients face is 
they don't have the kind of funding mechanism that Congress es- 
tablished for kidney transplants. Medicare will now pay for kidney 
transplants, but liver patients have to mount either a nationwide 
publicity campaign or in some other way raise the funds on their 
own before they can even get on the list. 

Mr. Fiske said that Jamie couldn't even get on the list to be con- 
sidered for a transplant until he could work out the financial con- 
siderations with Blue Cross-Blue Shield. It really shouldn't be that 
way. 



271 

Mr. Fiske. She was placed on the list on the 29th of September, 
the same day that Blue Cross-Blue Shield authorized funding for 
that. 

Mr. Gore. So just as soon as you got the authorization, she was 
put on the list? 

Mr. Fiske. She had gone out there for a 2-week evaluation. They 
were ready to make that decision on that Thursday. That Wednes- 
day, Blue Cross-Blue Shield called and said we are not going to 
honor the letters we have given you. She was placed on it on the 
29th, the same day that they authorized payment. 

Mr. Skeen. Mr. Chairman, I think that is an interesting point 
and one that we should resolve through these hearings; that is, the 
fact that medicaid and medicare, are willing to pay $250,000— they 
have that much exposure — on a person that is going to die. 

On the other hand, it is more cost effective to enter into the pro- 
grams of transplants at this stage, and with the stage of success 
that we have it would be far less expensive. 

I hope that we can maybe make some kind of determination 
along that line as we go into the discussion on this because it 
would be a very interesting economic discussion. It is probably 
much more costly to let someone die. You lose, particularly in the 
case of these young patients, the productivity of a lifetime from the 
individual as opposed to being willing to pay for the death or 
absorb the cost of dying, which is extremely high in itself. 

I would like to see if we can make some of these comparisons and 
then come up with some resolve from this group to encourage the 
private insurance suppliers or the private carriers, as they are 
called, and the Federal Government to change its mind in some 
regard to accept and to accommodate itself to the new techniques 
and new technology involved in transplants. We have made the 
breach now with kidneys. Why not livers and some of the rest of 
the transplant procedures that have proven high success rates? 

Thank you very much, Mr. Chairman. 

Mr. Gore. Thank you. 

Congressman Reid. 

Mr. Reid. Thank you, Mr. Chairman. 

I would like to acknowledge the great education that I have re- 
ceived the last couple of days and commend you and the staff for 
putting this hearing together. I think the whole Congress is fortu- 
nate to have you involved in setting some of the things that we are 
doing. 

The reason we are having this hearing is basically because Chair- 
man Gore, as the chairman of this subcommittee, looked into dif- 
ferent areas that needed attention in the science and technology 
field. I again, Mr. Chairman, publicly commend you for this hear- 
ing and certainly congratulate the staff on putting together a well- 
rounded panel. 

I have been touched a number of times today by the statements 
that have been made by various people. I don t know of anything 
that we could do that is more important than dealing with saving 
lives, and that is what, in effect, we are doing today. 

Mr. Fiske, let me ask you a question. This probably in the overall 
scheme of things is not important, but it is a question of curiosity 
in my own mind. 



272 

With adoptions, we do everything we can to keep the identity of 
the natural parents away from the child. You have had such a 
close relationship with this Utah family, the Bellon family, do you 
feel that it is desirable that you know who the donor is? 

Mr. Fiske. I think in our circumstance we could probably only 
deal with the family in Utah. The general feeling we had picked up 
from the staff at the university hospital in Minnesota was that the 
donor remain anonymous. 

We respected that kind of decision because it is a very, very 
tragic time for that family, to face that kind of issue. We knew 
that we would have liked to have had contact with them, but we 
respected the wishes of the experienced people at Minnesota sug- 
gesting that that remain anonymous. 

When we got a call from the social worker at Primary Children's 
Hospital in Salt Lake City, she said that the family would appreci- 
ate hearing from us either by telephone or by writing. 

We were delighted to be able to do that because we knew, as dif- 
ficult as it was for us to talk with them, we needed to be able to 
say to them thank you, not even having the words to say thank 
you, but just to have that kind of contact to let them know that 
they did something for Jamie that nobody else in the country was 
able to do at that time; that is, to think beyond their own tragedy 
and to think of giving Jamie hope, the hope of getting better. 

We are fortunate in our situation that the family is encouraged 
by Jamie doing well. The tragedy of their own situation, they are 
handling that now. It is, I am sure, very difficult and very painful 
for them to do, where their son was IIV2 months old. 

We couldn't say that that should be the case across the board, 
that everybody have contact with the donor family. We do know 
that in our own situation we have had contact with them. 

We realize how difficult in some ways it was for them, but the 
thing that keeps coming through from the family when we talk 
with them is how is Jamie doing, how much does she weigh, is she 
sitting up, is she talking, thank you for the pictures that you sent 
out. There is that sense of extension out of their situation. We 
don't get from them a sense of bitterness. We do get from them a 
sense of hope that Jamie will continue to do well. 

Right after the operation — there are high points and low points 
with Jamie's getting better. We could share those moments with 
that family because they wanted her, as well as we wanted Jamie, 
to get better. 

How that would work for other situations and other families we 
really don't know, but our experience with the Bellon family in 
Utah, we are excited that they are excited about her doing well. 

As I mentioned before, they have become part of Jamie's ex- 
tended family. They, in the midst of a very tragic situation, offered 
hope. I think a family doing that, in the midst of a tragic situation, 
gives hope and gives life to that family out there that does need 
that particular organ. That is what we are talking about, is a gift 
of hope and a gift of life. 

Mr. Reid. Mr. Chairman, I have a question I would like to ask 
Dr. Ogden. 

Doctor, first of all, is there a need for donor centers, a central 
place, a regional central location where the donated organs would 



273 

go? It would seem to me that many of the small institutions where 
people die in the sense like we heard yesterday, where their brains 
are gone but their bodies, they want them to keep working. Maybe 
we need a central location for donors of organs. 

Second, the second question, would more money mean more 
transplants, generally, not just kidneys but things in general? 

Dr. Ogden. Let me respond to the first question first. 

We don't need a donor organ center because you are speaking es- 
sentially of an organ bank. The organs we are talking about can't 
be banked. They have to be maintained in a living state or a recov- 
erable-to-life state. 

The time between removal of the organ from a donor and place- 
ment of the organ in the recipient varies according to which organ 
we are talking about. The longest is for kidneys. We don't like to 
see it go much beyond 24 hours, up to perhaps 36 hours. 

Actually, the organ is obtained by a group, which can be local, or 
a group can go to the hospital to obtain a kidney or other organ. 
This is done all the time. Then the organ is transported to where 
the waiting recipient is. 

The second question was whether more money would mean more 
organs. I think in the broad sense you can say yes, but the hangup 
is not specifically money. I think it is very hard to get to the real 
core of this. 

I recognize, first of all, that almost all usable organs come from 
healthy, relatively young — middle-aged or less, usually — people 
who were doing their thing moments before or hours before and 
who have a sudden tragedy. In this country at this time, that usu- 
ally means motor vehicle accidents, cars, motorcycles. Not always, 
but usually. 

I am particularly gratified to see that the two transplants repre- 
sented here at this table, in both instances the family of the donor 
came forward. I think we need to recognize that it is very difficult 
to have the health care team caring for the potential donor recog- 
nize the potential of that situation and come forth and suggest do- 
nation. 

In fact, the health care team caring for the donor, their job is to 
represent the donor's interest. By the time they recognize that 
death is imminent, donation may be impossible. The potential 
donor may be in such medical condition by the time the care team 
caring for that patient — the physician, ICU nurses, et cetera — are 
willing to say this person is in fact going to die, that in fact they 
are not a donor anymore, they are not suitable as a donor any- 
more. 

So, the problem of identifying somebody who is going to go 
around and say this is a potential donor puts that person, whoever 
that is — a transplant coordinator, an ICU nurse, another physi- 
cian — in conflict with the best interests of the care team caring for 
the person who might have been or might be a potential donor. 

All I am saying is that it makes it very difficult to find that fine 
point in time between which a person is in fact dead, or about to be 
brain dead, and still is not so dead that the organs are not useless. 

That is part of the problem, resolving that problem. When the 
family suggests the potential of donation and recognizes the futility 
of the situation, then it becomes so much easier because they have, 



274 

in fact, recognized it. It is possible now to think that way. It is pos- 
sible for the care team to think that way. 

Mr. Reid. Thank you, doctor. 

Thank you, Mr. Chairman. 

Mr. Gore. Congresswoman Schneider? 

Mrs. Schneider. Thank you. 

Mr. Fiske, I think that it is interesting to note that you went 
through a great deal of struggle in order to get your message 
across, that you were looking for a liver for Jamie. It was through 
the media that you were able to locate a donor. 

Michele, it was pretty much the same situation. It was through 
the media, somebody hearing on the news that you were seeking 
the need of an organ transplant. 

Mr. Fiske, I would just like you to make some comment as to the 
role you see in the future to try to improve the connection between 
the supply and the demand of organs, what role you see the media 
playing in the future. 

Mr. Fiske. In some of the stuff that we went through, it was 
myself and Marilyn sitting down on a daily basis, making the kind 
of decisions like where to go and how to go about it. One of the 
things we didn't have was a clear game plan of what to do. It was 
the kind of day-by-day decision, once Jamie got put on the list, to 
figure out where to go. 

Anything we did, we always bounced off the medical community 
in Minnesota, running it by them. One of the things we didn't want 
was that the media make medical decisions. We didn't want the 
media to come in and say — we wanted the doctors to make that 
kind of decision. We also wanted the doctors to know that we were 
taking steps. So both of us actively traded off the privacy we had 
with the possibility of Jamie getting better. 

Our intention in going to the American Academy of Pediatrics 
was to go back to the medical community, to doctors, predominant- 
ly pediatricians, so that they they could raise — one of the things 
that I mentioned when I addressed them was that the trauma we 
are talking about for your situation may not have already hap- 
pened. 

What we were hoping was those pediatricians would go back, 
raise that issue in that relationship that they have with their fami- 
lies and the patients that they treat. It is kind of a sacred relation- 
ship that they have, where you entrust your children to the pedia- 
trician's care. So, we went through that. 

The media's involvement in that was very clear, in getting that 
message from New York City to Alpine, Utah. There was a family 
watching that, but it was in front of a medical forum that that was 
done. 

As a result of our original intentions with that particular medi- 
cal group, I have had calls from doctors. A doctor in Missouri 
called me. He had been at the convention. I got a call several 
weeks ago, and he said he had heard about that stuff. He was 
treating a patient named Kelly Johnson, and he wanted to know if 
I could give him the names of the doctors in Minnesota so he could 
call them. It was interesting because the thing we wanted for 
Jamie, this doctor had picked up on, was responding to, and getting 
involved in this particular case of biliary atresia. 



275 

What the role of the media is, in our situation the media were 
always fair to us. There wasn't a massive invasion of privacy. We 
turned to the media willingly and knew that what we considered as 
privacy, to hold on to that may cost us any help for Jamie. 

Mrs. Schneider. I understand that, but it seems to me that your 
experience clearly denotes that anyone who is in a similar situa- 
tion of looking for an organ ought to have a media game plan. I 
think that certainly that was one element that helped. 

Yesterday in our testimony we heard how there are many nurses 
that are aware of possible deaths among some patients, and they 
are becoming more involved now in providing that information 
link, which seems to be the missing link in all of these discussions. 

Mr. Fiske. To say the media has to be the salvation of everybody 
that needs a transplant I don't think is accurate. In our particular 
situation that was a choice that we made. That doesn't have to be 
the choice for every single family. It may not be. 

Mrs. Schneider. But you succeeded, and I think it is an example 
where others probably will try to follow in your footsteps. 

Mr. Fiske. What may have been right for Jamie may not be the 
way to go for every family. I think what has to be in place is some- 
thing a lot more secure than media coverage of the situation; in 
other words, there has to be a system in place to do that so that 
the likes of myself and Marilyn don't have to go to the likes of Sen- 
ator Kennedy, Senator Tsongas, Congressman Moakley, the Speak- 
er of the House, asking them to assist us, and then going back to 
the media or going to the American Academy of Pediatrics. 

I think what happens is that that may happen once or twice, but 
after a while that may lose some effect that it may have. I think 
what needs to be in place is something is a lot more long lasting 
than the immediate need of one child, something that families who 
are not facing this will have a sense of hope that we really didn't 
have. 

Mrs. Schneider. I think it is quite clear that your comments now 
are indicative of how disorganized the structure is in order to solve 
the problem. I think that one of the efforts to solve the problem is 
the donor alert program, the 800 number. 

Your neighbor to the south, in Rhode Island, my constituent, was 
here testifying yesterday. Are you familiar with the program that 
he has set up? 

Mr. Fiske. I have talked with Ray Coleman. As a matter of fact, 
we were talking about getting together prior to this week, but our 
schedules were so conflicting. 

I think Ray's background had been law enforcement and was 
very keenly aware that the role that police officers have in terms 
of identifying situations that are in the middle of the night, they 
are looking for the name of the person that may be involved in an 
auto accident, and their ability to say to the EMT or to the doctor, 
gee, this particular person here has a donor identification tag on 
his license, to think about that as they are bringing the person in. 
I think again that is that whole other area of support personnel 
with the medical community. You have people like Ray who are 
very much involved in it from his perspective because of that group 
of people, called law enforcement, who see tragedy more regularly 



276 

than most of us. His effort to bring that out I think again is one 
person who sees a need and is trying to do something for that. 

It is encouraging, especially with the Pinheiro family, Ray called 
me the day before we came down here to mention that Justine had 
received notification from Pittsburgh. I think Ray is thoroughly 
committed to that, much as we are now as a family, because 
nobody should be in the same situation that we were. 

If there is anything that we can do — and I am sure Ray feels the 
same way from his perspective — to alleviate some of that burden, 
as far as organ donor awareness, we are thoroughly in support of 
that. 

Mrs. Schneider. I am delighted that you mention it because that 
is the perfect lead-in to my next comment. 

As you know, this committee is going to be making recommenda- 
tions after our 3 days of hearings. Granted, some of them will be 
very substantial in reference to the cost concerns of financing these 
operations. We will be discussing with the Federal officials and the 
medicare system what solutions are possible. 

But there is obviously a need for continued citizen participation, 
and it seems to me that if we move along the lines that have al- 
ready been initiated, for example, having the communications link 
with all of the doctors and nurses across the country, that is ex- 
tremely vital. 

I would also be inclined to make the recommendation, as Mrs. 
Thiel has mentioned earlier that the many groups across the coun- 
try get together and work as a team to provide a support system. 

It is quite clear that not only is the money necessary along with 
the donor location, but the family also needs some kind of support 
system. I think that is the kind of public service that can be pro- 
vided by many of these nonprofit organizations and individuals, 
such as yourself. 

So, I am hopeful that your organizations and the individuals who 
are concerned will closely read our recommendations because I, for 
one, having come from the public sector and being a citizen activ- 
ist, am supportive of all efforts such as your own, but obviously 
there is a need for coordination and coalition building. 

I am hopeful that you will pick up that ball and keep running 
with it because that is a very vital part of the whole solution to 
this. 

Mr. Fiske. Tuesday morning I met with the National Kidney 
Foundation of Massachusetts, the Massachusetts General Hospital 
Bone Bank and the New England Organ Bank. Their feeling was 
that they don't have money in their budgets to do public aware- 
ness. 

Their thrust in their organizations is transplantation, identifica- 
tion of donor organs, preservation of those organs, but they don't 
have the ability to go out and educate the general public. 

Their feeling very clearly, at least in the New England area, is 
any kind of support that they could back into, they would be will- 
ing to go hand in hand with that; if they could turn that public 
awareness over to a particular group to be able to do that, because 
again they don't have the ability to do that. 

Mrs. Schneider. We should begin to focus on the New England 
region, I for one will volunteer, and I am sure I can work with Con- 



277 

gressman Moakley and put together a couple of ideas and see if we 
can coordinate our efforts. 

Mr. Fiske. Again, anything that you would need from myself and 
Marilyn, we would thoroughly support that. 

Mrs. Schneider. Thank you very much. I appreciate your testi- 
mony and your presence here today. 

Thank you, Mr. Chairman. 

Mr. Gore. Congressman Durbin? 

Mr. Durbin. Mr. Fiske, Mrs. Fiske, when you were waiting for 
that letter from Blue Cross, did you have a contingency plan in 
mind, what you were going to do if they said no? 

Mr. Fiske. The overriding thought in our mind — and this is, 
again, speaking for both of us — was we did not want Jamie to die. I 
think what happened was Jamie had a very healthy period from 2 
months to about 5 months and then the disease she had advanced 
pretty quickly. Anything we could have done we would have done. 

Again, funding very clearly is an obstacle and it caused us a lot 
of aggravation, a lot of worry, and it could have meant her not get- 
ting that operation. 

I wish that was the only obstacle. The biggest obstacle that we 
faced that we had no control over was her declining health. The 
second major one was identification of a donor. After that, I would 
put the issue of funding. 

That is not to downplay the role of funding, but making her 
better and identifying $100,000, if it was that simple, then you 
would do that. If we thought getting $100,000 would make her 
better and we would go back to Massachusetts and say goodbye 
Minnesota, it would have been great. 

Funding did present an obstacle. I think what we would probably 
have had to do — we went, again, through Governor King at that 
point in Massachusetts and requested medicaid approval for Jamie. 
Since she had been declared disabled, having been in the hospital 
longer than 70 days, we had petitioned the Department of Public 
Welfare that she be approved for medicaid funding. Through Gov- 
ernor King's office, the commissioner, Tom Spirto, on October 29, 
authorized funding for her for that operation. 

Mr. Durbin. Would that have required some kind of means test, 
as far as you were concerned, that you would have surrendered a 
certain amount of your assets, your family assets? 

Mr. Fiske. No. That is one of the questions that had come up. In 
Jamie's case, since she had been in the hospital longer than 70 
days she, under social security, was declared disabled. 

Apart from any assets that we would have as a family, being de- 
clared SSI eligible in her case made her eligible for medicaid in 
Massachusetts. Being eligible for medicaid allowed us to go ahead 
and petition the commissioner of public welfare to give prior ap- 
proval to that type of surgery. 

The difficulty that that presents with Blue Cross-Blue Shield is 
that there was no guarantee, even though they put in writing that 
they would follow through. Also, with medicaid, it is a case-by-case 
decision. 

The problem we had was the time factor. Her surgeon, the day of 
the surgery, came down the corridor to us, Dr. Najarian, and Dr. 
Ascher. He looked at us and then he looked down at his hands and 



278 

said, right after the operation, "Looking at her liver, I would have 
given her 10 days to live." So, we knew time was running out. He 
very clearly told us on November 5 that time was 10 days ahead 
for her dying. 

I think we would have had to raise that kind of money in a door- 
to-door campaign. The citizens of the Commonwealth of Massachu- 
setts, as well as the town of Bridgewater, we never really asked for 
money. People sent us money in envelopes. 

The Governor declared Jamie Fiske Day November 12, for the 
purposes of offsetting some of those supporting medical costs. Citi- 
zens in Minnesota, through Senator Rudy Bosch witz, set up a fund 
out there to offset some of those living costs, some of the flying 
back and forth between Boston and Minnesota. 

People were extremely generous, their wanting to help us as a 
family, not only in Massachusetts and Minnesota, but we got let- 
ters from as far away as Texas, California, Maine, of people want- 
ing to help by sending money. 

It would have involved us petitioning people for that kind of 
money to take care of it. Again, the obstacle that that presents is 
the day that Jamie was put on the transplant list, September 29, 
was the same day that Blue Cross-Blue Shield authorized the pay- 
ment for that operation. 

Mr. Durbin. So you had to have the money before you made the 
list? 

Mr. Fiske. In true justice to the University of Minnesota, they 
never held Jamie's health care in ransom. They told us very clear- 
ly to secure the funding before we came out, but they never said, 
we are not going to treat her and send you back home unless that 
money is in place. 

But it is coincidental, though, that they did ask that we get that 
in writing from Blue Cross-Blue Shield. When she was put on the 
transplant list was the same day that Blue Cross-Blue Shield did 
come through. 

Mr. Durbin. Mrs. Thiel, you testified earlier, and I guess you put 
it together in a couple words very succinctly, about this tin cup 
syndrome. We have heard the testimony from Mr. Fiske about 
what he and his wife faced if they couldn't get the Government ap- 
proval and if the private insurance company had said no. 

The thing that crosses my mind is how many people have the 
awareness in their own mind of what can be done? How many 
people are intelligent, have enough drive in a situation with per- 
sonal adversity that they are going to start searching for the media 
and looking around? How many are poor and wouldn't know where 
to start? 

I am just wondering if you have any thoughts about that whole 
tin cup approach and what we ought to do about it. 

Mrs. Thiel. I think there are very few people that are as sophis- 
ticated as the Fiske family and have the contacts and would know 
what to do. I know that years ago, when my son was diagnosed, I 
would not have known where to begin. 

When these families call, they are really at their rope's end. 
Some of them have been told that they have to have upfront 
money of $300,000 before they will even consider evaluating their 



279 

child. That is a desperate situation. I don't know where I would go 
for $300,000. 

As I say, the only thing that we can do is give them guidance, to 
talk to your insurance company. You really have to do battle with 
your insurance company. Don't take no for an answer. Talk to your 
legislators. See what coverage your carry from medicaid-medicare 
in your area. 

Then, of course, try to get some of the local organizations, the 
fire department, the junior league, and so forth, some of the civic 
organizations, to help you to raise that money. This has happened 
in many areas. 

Again, I think as more awareness is created through radio and 
television programs, that people are doing this. I think that the 
media has been very, very responsive to the needs of a lot of these 
families. 

Mr. Durbin. There have been suggestions, and we have heard 
them from time to time, about some efforts in the Government, on 
the Federal and State levels, toward catastrophic insurance, to help 
families in this particular predicament when the medical bills have 
gone beyond a certain point and gone beyond the means of most 
American families. 

What do you think of that? Do you have any problems with that 
in your own mind of embarking on that kind of program, even 
though we are living in pretty difficult times economically? 

Mrs. Thiel. We are always looking at the dollars. Of course, liver 
transplants have come into view much more recently. I don't be- 
lieve that a kidney transplant is as costly in general as a liver 
transplantation. But when you consider the value of a life com- 
pared to the cost of that liver transplant, I think that there is no 
question in my mind at all. 

Mr. Durbin. I knew you would answer that way. 

Dr. Ogden, yesterday I mentioned to the panel that when I 
worked in the Illinois State Senate we adopted the Uniform Ana- 
tomical Gift Act. We tried to make some progress with our driver's 
licenses, to put the consent on the back of a license. 

Do you feel that that, aside from increasing public awareness, 
which I think it has done, has really created a good link between 
donors and recipients when it comes to organ transfer in your own 
mind? 

Dr. Ogden. No, I don't think it has. I think it has increased 
awareness. In that regard, we are beginning increasingly to see 
families who, in the appropriate circumstances, request a consider- 
ation of donation. The initiative is increasingly coming from the 
next of kin of the injured person. So, I think it is helping in that 
indirect sense. 

It is rarely that the driver's license is used as the legal document 
through which transplantation is achieved. It happens, but it is 
rare. 

My particular suggestions were that the recorded wish of an indi- 
vidual on their driver's license be, in fact, noted on admission of 
anybody to a hospital of significant size, in the hope that, in fact, 
one that would lead all along the trail the health care team and 
the individual and family, because if they request the driver's li- 
cense to record your donor status, immediately you have focused 



280 

attention on that without saying we want you to make a decision. 
Now you are sick, we want you to make a decision about whether 
you want to be a donor I don't think that is appropriate. 

I do think that if you have already made that decision, it focuses 
on it slightly but doesn't make a big deal of it, to say let's see your 
driver's license and record what is on there. It also would increase 
the sense of it throughout the hospital. Wherever the patient went, 
this would basically be recorded. I think in that way we could 
begin to make use of the driver's license. 

By the way, there is no uniformity from State to State about the 
way in which this is handled. In at least one State you must make 
a declaration of yes or no. Well, faced with having to say right now 
whether you want to be a donor or not, most people put no. 

In some States it is entirely optional. In some States you are 
asked whether you want to make a declaration. In other States you 
aren't asked, but if you ask them, if you would know enough to ask 
at the driver's license bureau, they would say oh, yes, and then 
they will pull out an affidavit and record it on there. 
Mr. Durbin. I think that is most people's experience. 
Dr. Ogden. So, there could be room for gaining a greater degree 
of uniformity about how this is handled, assuming there could be 
that kind of agreement on a national basis. 

Mr. Durbin. Can I ask you two other questions somewhat related 
to that in your experience? 

Have there been problems related to the definition of brain 
death, in terms of all States not adopting the same standard, that 
have resulted in delay or the loss of a donated organ? 

Dr. Ogden. Yes, there has even been active resistance in some 
States by various facets of the medical community and lack of the 
ability to come to agreement. 

The wording of the uniform brain death law, which has been 
adopted by 28 States, I believe, seems satisfactory although actual- 
ly that wording hasn't been adopted by 28 States. Twenty-eight 
States have a brain death law, not always of the same wording. 

I think again this is an area we need to encourage. In some 
States, declaring a person brain dead is not a legal way to declare 
death. 

There is an opportunity here— perhaps this hasn't been com- 
mented on. A brain death law serves more function than simply in 
organ donation. It establishes criteria by which brain death can be 
pronounced whether or not organ donation is even a consideration. 
If the individual, for instance, is 70 years old, that person is prob- 
ably not a potential organ donor for any of the organs we have 
been talking about today. Yet, in the absence of a way to recognize 
and pronounce brain death, there is a likelihood that the care will 
be extended beyond that point which might otherwise be necessary, 
at additional expense. 

What I am saying is that a brain death law can be cost effective 
in terms of not providing unnecessary medical care. 
Mr. Durbin. Thank you very much. 
Thank you, Mr. Chairman. 

Mr. Gore. The subcommittee just received a communication from 
LeBonheur Hospital in Memphis that Brandon Hall's condition is 
good. The prognosis is good, but the condition is critical. They are 



281 

saying that his chances are 50-50. There was a 12-hour operation. 
Doctors announce that he suffered cardiac arrest twice during the 
operation and, as a result, they are cautiously optimistic. I am sure 
we will be hearing a good deal more from LeBonheur. 

If I was asked to summarize the basic purpose of these hearings, 
Mr. and Mrs. Fiske, it would be this. Parents should not have to go 
through what you had to go through in order to save the life of 
Jamie. They should not have to experience what Mrs. Hall had to 
go through in order to try to save Brandon's life. 

There are many Jamie Fiskes and Brandon Halls, and there are 
going to be many more to come. We need to save them by design- 
ing and establishing a national strategy that will help parents in 
the situation that you found yourselves in, to remove the obstacles 
of financing, to remove the obstacles in the form of increasing 
awareness among American citizens about how important organ 
donation is, and to better organize the organ procurement system 
nationwide, so we can save these children's lives in the future. 

I want to thank all of our witnesses on this first panel for being 
with us. You have helped us in our effort. We are precisely halfway 
through our 3 days of hearings. I would like to thank you again for 
helping us out. 

Mr. Fiske. Thank you, Mr. Gore. 

Mr. Gore. Our next panel is made up of Prof. Alexander Morgan 
Capron, Executive Director of the President's Commission for the 
study of ethical problems in medicine and biomedical and behavior- 
al research; Dr. Robert Veatch, professor of medical ethics and 
senior research scholar at the Kennedy Institute of Ethics at 
Georgetown; and Dr. James Childress, professor of religious studies 
and professor of medical education in the Department of Religious 
Studies at the University of Virginia in Charlottesville. 

I would like to welcome all three of our witnesses here today. 
Professor Capron, as Executive Director of the Commission on 
Bioethics — that is what I call it, rather than its long name — we 
have had an opportunity to talk with you on several occasions. 

As you know, we have the highest regard for the work you have 
done, and we are honored to have you leading off this panel on the 
bioethical considerations involved in a national strategy for organ 
transplantation and organ procurement. 

Without objection, your entire prepared statement will be includ- 
ed in the record. Please proceed with your presentation. 

STATEMENTS OF ALEXANDER MORGAN CAPRON, EXECUTIVE DI- 
RECTOR, PRESIDENT'S COMMISSION FOR THE STUDY OF ETHI- 
CAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAV- 
IORAL RESEARCH; DR. JAMES CHILDRESS, PROFESSOR OF RE- 
LIGIOUS STUDIES AND PROFESSOR OF MEDICAL EDUCATION, 
DEPARTMENT OF RELIGIOUS STUDIES, UNIVERSITY OF VIR- 
GINIA; AND DR. ROBERT M. VEATCH, PROFESSOR OF MEDICAL 
ETHICS, SENIOR RESEARCH SCHOLAR, KENNEDY INSTITUTE 
OF ETHICS, GEORGETOWN UNIVERSITY 

Mr. Capron. I appreciate the opportunity to testify, in civilian 
dress, now that the Commission has concluded. From an ethical 
and legal vantage point, it seems to me that the central question is 



282 

what should society's response be to the need of tens of thousands 
of Americans for complex and expensive forms of treatment for 
grave illnesses, particularly when the treatment draws on limited 
resources and, though of demonstrated value, is still partially ex- 
perimental. 

Because of the lateness of the hour, I want to abbreviate very 
much what I have to say and offer an opportunity for any ques- 
tions. I divided my observations into those which deal with the 
scarcity of organs and the scarcity of funds. 

SCARCITY OF ORGANS 

Looking first at the question of cadaver organs, there are three 
issues: First, the lingering uncertainty about the determination of 
death, which we just heard about in the exchange with Mr. Durbin; 
second, the lack of adequate donations; and third, the inadequate 
coordination of the organ donor process. Let me make a few obser- 
vations on these. 

You are familiar with the work of the President's Commission on 
the Determination of Death, and I have summarized that in an at- 
tachment to my statement. The Commission, along with the Na- 
tional Conference of Commissioners on Uniform State Laws, the 
American Bar Association, and the American Medical Association, 
recommends the adoption of the Uniform Determination of Death 
Act. That law is now effective in 14 jurisdictions. We are waiting 
still for congressional action on that, which was contemplated in 
the 97th Congress, and might happen in the 98th, to cover Federal 
jurisdictions and as a spur to State adoption. 

The Commission strongly recommended that the adoption of the 
statute be kept separate from the Uniform Anatomical Gift Act, 
which is law in all 50 States and the District of Columbia, because 
the two subjects, although linked, are not coterminous. 

The second question, which deals with the inadequacy of the 
supply of organs, relates to the fact that despite the comments that 
were just made by the representative of the Kidney Foundation, I 
do not believe that we know what part of the population has taken 
steps to make an inter vivos gift, an intention to give a gift, that is, 
under the Uniform Anatomical Gift Act. 

Several alternatives for increasing donation above the level 
which now exists would involve changes in the law. The first would 
be going to a system of payment either made to a person during 
the lifetime to be binding at the time of death, or made to rela- 
tives. Given our poor history with the sale of organs, such as blood, 
already I believe most commentators in this field view a movement 
toward a marketplace in organs as an unfortunate step. Certainly 
most physicians object very strongly to this. 

Mr. Gore. You see no evidence of that, do you? 

Mr. Capron. One sees evidence of it from time to time — ads in 
newspapers offering organs, kidneys, corneas, things like this — but 
I think it is a very unusual thing still because most physicians 
don't want to participate. 

Of course, a seller and buyer could engage in an arrangement in- 
dependent of the knowledge of the physicians involved. It is not un- 
usual when there has been a true donation for the donor to have 



283 

medical expenses paid. There is a fine line between paying medical 
expenses and paying time off from work, if you are talking about a 
live donor, and so forth, or expenses of the funeral, if you are talk- 
ing about a deceased donor. So, there is a shading between a 
market system and a donation system. 

The major objection, I think, is that the present system, which 
involves a gift relationship, has certain important values for soci- 
ety irrespective of the practical question of whether one would, as 
in the blood area, end up with organs that were less suitable than 
from a system of unpaid donations. For one thing, if you turn 
something into a market, the incentive for other people to be altru- 
istic to make a donation seems to be decreased. 

A second alternative at the opposite extreme would be an option 
of statutes allowing the State to take organs on a compulsory basis 
without consent as a routine matter, on the grounds that organs 
are valuable resources that a deceased person should not be al- 
lowed to destroy. In my reading of constitutional law, it would 
appear to require a high-level justification for such a taking, even 
from cadaver donor bodies. 

Mr. Gore. No one has recommended that one, have they? 

Mr. Capron. Oh, yes, it has been recommended. In 1968 there 
was a recommendation to that effect, a law journal article detailing 
that. That is all in my materials that I provided to the committee. 

Mr. Gore. Thank you. 

Mr. Capron. The third is replacing what we now have, which is 
sometimes referred to as an opting-in or contracting-in system, 
with an opting or contracting out system; that is to say, to begin 
with the presumption that everyone would want to donate and 
then permit people during their life to indicate that they do not 
want to be included. 

One suggestion to that effect was made by Prof. Jesse Dukemin- 
ier of UCLA in 1968. The problem with his suggestion was that he 
would also allow the relatives to object after death. The major im- 
pediment to the use of organs at the moment is the uncertainty 
that surrounds the point of donation: Has the person made a 
choice? What are the relatives' wishes? Can the relatives be con- 
tacted in time? Does one feel comfortable intruding upon their 
grief by discussing this subject with them? 

If we were to have an opting-out system, that included relatives, 
as Dukeminier proposed, I don't think we would gain anything. If 
you had an opting-out system which only relied on the individual's 
own choice, it would seem to me to be very probable that we would 
gain in terms of the number of organs because public opinion polls 
done on this subject for the last 15 years have shown that the 
public by overwhelming numbers, 70 to 80 percent favor donations 
and would wish to make a donation. Yet, we know that only some 
far lower proportion of people actually fill out the cards during 
their lifetime — though I don't know anyone who has good statistics 
on this, despite statements that are made. 

All of these alternatives deserve some exploration, but I for the 
moment would think that we need to give greater emphasis, as the 
previous panel told you, to increasing donations under our present 
system. 



284 

I think we have an excellent legal framework in the Uniform 
Anatomical Gift Act [UAGA] and the Uniform Determination of 
Death Act for donations. What we need is greater public informa- 
tion and education, to make people aware of this as something 
which they ought to do during their lifetime to avoid the grieving 
situation for their family. 

I would, therefore, urge you to lend your support to efforts by 
private, State and Federal groups to publicize the UAGA so as to 
preserve the great ethical as well as social values in voluntary do- 
nation. If that is judged inadequate to obtain needed organs for 
transplantation, I suggest at most an amendment of the UAGA to 
make donation automatic unless a person opts out during his or 
her lifetime. 

The third issue about donation from cadaver organs is the need 
for sharing of organs. Scarcity at the moment breeds a proprietary 
attitude toward organs among those who, in the term of art, ' 'har- 
vest" them. Even with kidneys, the attitude has been that the hos- 
pital at which the procedure is done will typically say we will keep 
one for one of "our" patients and put the other one into the 
system. 

The problem with this is that for a good match— and the better 
the match, even with present immunosuppressive agents, the 
better the likelihood of a good survival— you need to increase the 
pool of recipients and donors being compared with each other on a 
tissue-typing basis. 

Furthermore, it contradicts notions of fairness as well as good 
sense when organ availability depends upon the ability of particu- 
lar recipients or their family members to generate publicity for 
their plight. You can imagine that the news media are really not 
that interested after the first Jamie Fiske story and the second, 
third, fourth, and fifth liver transplant. The interest dies down. It 
seems to me that the spectacle, whatever cathartic function it may 
serve for the public once a donor is found, is contrary to our usual 
norms of the proper way in which medical care should be deliv- 
ered. 

Depending upon logistical considerations, I believe that a region- 
al or national system of organ transfers would be advisable, with 
support by local coordinators to facilitate the actual donations. I 
believe you should endorse surveillance and coordination by the 
CDC in this field. 

I won't elaborate in my comments now on my prepared remarks 
on living donors. It is a more minor issue. The case that came up 
recently in Iowa, it seems to me, was an unfortunate one and I 
hope that that decision by the judge is reversed on appeal, so that 
people understand that their participation in this system will be 
judged by the usual norms of confidentiality and they will not be 
subject to the kind of pressure that the judge apparently decided 
was suitable on that woman as a bone marrow donor. 

SCARCITY OF FUNDS 

The scarcity of funds raises a problem which we see now 
throughout medical care. The ethical issues posed for public and 
private decisionmakers are those that arise whenever scarcity is in- 



285 

volved, which are the questions of the societal obligation and of 
fairness. 

My two basic conclusions in this area are, first, that the issue is 
not how to avoid making difficult choices among people in need by 
throwing more money at the problem, but rather how to make 
such choices in a justifiable manner; and second, I conclude that 
we must develop means for determining how new medical develop- 
ments relate to society's obligation to insure equitable access to an 
adequate level of care. 

The availability of reimbursement through medicare's special en- 
titlement for end-stage renal disease hasn't ended our ethical prob- 
lems there. Physicians, nurses, hospital administrators still have to 
agonize over cases, asking whether a particular treatment should 
be used with a particular patient. Moreover, it is quite obvious by 
now that we cannot say "yes" to funding every treatment. We 
must instead make sure that we don't say "no" unfairly. 

In addressing the issue of society's ethical obligation toward 
health care, the President's Commission determined that the stand- 
ard of equity requires that everyone have access to an adequate 
level of care without the imposition of excessive burdens. 

Defining adequacy is clearly a difficult task. To eliminate repeti- 
tion on this point, I have set forth the Commission's discussion in 
one of the appendices to my statement. 

Of greatest relevance here are two points: First, while judgments 
about whether a particular treatment are not solely matters for 
professional judgment, expertise of the sort that the National 
Center for Health Care Technology in HHS was beginning to devel- 
op before it was abolished, regarding the reimbursement under 
Federal health care financing programs, could certainly be very 
valuable. 

Second, since the greatest test of fairness will probably be compa- 
rability, decisionmakers, particularly those in the public sector 
whose decisions are likely to be generalized, must keep in mind the 
tendency of limited acts of generosity to have very broad ramifica- 
tions. 

I urge that you explore with HHS its ability to assess the rela- 
tionship of particular treatments, not just organ transplantation, to 
the adequate level of health care that should be guaranteed by so- 
ciety to its members in a manner that is fair and consistent. 

I regret, Mr. Chairman, I think as you and your staff knew, I 
have an obligation to teach a class. I have 125 students waiting. 
With the indulgence of my copanelists, I would welcome your ques- 
tions now, Mr. Chairman. 

[The statement of Mr. Capron follows:] 



23-029 0-83-19 



286 

Statement of Alexander Morgan Capron, Professor of Law, Ethics and Public 
Policy. Georgetown University Law Center 

ETHICAL AND LEGAL ISSUES IN ORGAN REPLACEMENT 

Good morning, Mr. Chairman and members of the Subcommitte, 
and thank you for inviting me to address some of the legal and 
ethical issues in organ transplantation. I applaud your decision 
to take up this important and timely topic and hope that my 
remarks will be helpful in your explorations. 

As the chairman has already mentioned, I was until just 
recently the director of a presidential commission that studied a 
wide range of bioethical problems. Although I will draw on the 
work of that commission in portions of what I have to say today, 
I am not speaking on behalf of the Commissioners. Indeed, while 
a number of the 11 reports of the President's Commission touch on 
today's topic, the Commission did not study the subject directly. 
From an ethical and legal vantagepoint, the central question 
as I see it is: what should society's response be to the need of 
tens of thousands of Americans for complex and expensive forms of 
treatment for grave diseases (usually chronic in nature but also 
imminently life-threatening) , particularly when the treatment 
draws on limited resources and, though of demonstrated value, is 
still partially experimental? That is a complex question which, 
I believe, captures most of the issues I'd like to address. 

I. SCARCITY: ORGANS 

You have already heard, yesterday and earlier this morning, 
about the numbers of patients with kidney, heart, liver, or lung 
conditions who might benefit from organ transplantation or 
mechanical substitution. I would like first to discuss the 
issues raised by their need for organs for transplantation. In 



-1- 



287 



the case of most organs, the only source is a cadaver; in the 
case of kidneys, as for bone marrow and blood products, there are 
two sources for such organs: living donors as well as cadavers. 
These two sources raise somewhat different issues. 

A. Cadavers 

Under the Uniform Anatomical Gift Act (UAGA)--the most 
successful act, in term of uniform adoption, of any proposed by 
the NCCUSL — a simple and effective method already exists in every 
state for the donation of cadaver organs. If organs were 
obtained for transplantation from all people who die each year 
under circumstances that would make them suitable organ donors 
(and if these organs were then distributed in an efficient 
fashion) , there would be more than sufficient supply for present 
estimates of need and medical capability. Unfortunately, this is 
not now the case for several reasons: (1) lingering uncertainty 
about the legal "definition" of death; (2) lack of adequate 
donations, by people during their own life or by their relatives 
after the patients' death; and (3) inadequate coordination, 
locally, regionally and nationally. 

1. "Definition" of Death 

The first statutorily mandated subject addressed by the 
President's Commission was the "definition" of death. This 
subject is, as you know, relevant to organ transplantation, 
because to maximize their potential benefit to recipients, organs 
should removed as quickly after the donor has died as possible, 
preferably while they continue to be nourished by oxygenated 



288 



blood circulating as a result of artificial support of the 
deceased's heart and lungs. 

For the sake of brevity, I have appended to these remarks 
the summary of our conclusions from the opening pages of the July 
1981 report Defining Death (Attachment A) . The two points most 
relevant, here are: first, that the Commission, along with three 
other leading groups, recommended adoption of the Uniform 
Determination of Death Act (UDDA) , which is now law in 14 
jurisdictions, including the District of Columbia, although 
consideration of an enactment for areas under federal 
jurisdiction, which was expected in the 97th Congress, never 
occurred; and second, that the Commission urged that the UDDA be 
kept separate from the UAGA. Although it was the advent of heart 
transplantation that brought the issue of "defining" death to. .the 
public's attention— and, indeed, that prompted the medical 
profession's attention to the conclusions of the 1968 Harvard Ad. 
Hoc Committee (205 J. A.M. A. 337) —the need to update the legally 
recognized standards for determining that someone has died does 
not rest primarily on any need to facilitate organ transplan- 
tation but on the confusion created for the old heart-lung 
standard by the use of modern forms of treatment that can 
simulate the traditional "vital signs" in patients who are 
actually dead. (See Attachment B for excerpts from the 
Commission's report on this point.) 

Most American jurisdictions now have some form of modern 
"definition" of death. Greater public and professional certainty 
on the issue would be provided if the UDDA were adopted in all 



289 



jurisdictions, and if those people — principally physicians and 
public officials concerned with health issues — who educate the 
public on such matters were to be careful with their terms, so as 
not to perpetuate any lingering sense of "two kinds" of death 
( i.e. , one for organ donors, the other for the "truly dead") or 
of a "dead body" being maintained by "life support" equipment, 
and so forth. The reliability of modern medical criteria for 
determining that death has occurred is manifested by the 
guidelines of the Commision's medical consultants (Attachment C) , 
which the Journal of the American Medical Association hailed as a 
"landmark" event. 

I urge you to provide leadership on this issue, both 
through Congressional action on the UDDA and, even more 
important, through encouragement to the states to enact -- 
the UDDA . 

2. Inadequate Donations 

Public polls have consistently found that an 
overwhelming majority of Americans favor organ donation, yet only 
a proportion of the population — the exact figure is, to the best 
of my knowledge, unknown — has availed itself of simple procedures 
of the UAGA. A larger number of donations occur because the UAGA 
also permits specified relatives to donate the organs of a dead 
person who did not make a decision to so so during his or her 
lifetime; these choices are frequently complicated by having to 
be made in the context of the relatives' grief (and often shock) 
over the death of person, which has typically occurred suddenly 
and often violently. 



290 



In a book written a decade ago, Catastrophic Diseases; Who 
Decides What? , Dr. Jay Katz of Yale and I considered a number of 
alternatives to the UAGA, including a payment procedure, "opting- 
out" in place of "opting-in," or compulsory removal of suitable 
organs. From an ethical and social vantagepoint , all of these 
alternatives have the disadvantage of turning what is now part of 
a "gift relationship" into a "taking" or "sale" — but such 
considerations might be overridden if voluntary donations do not 
produce socially satisfactory results. (Again, for the sake of 
brevity, excerpts from our book are appended as Attachement D.) 
Since that time, some states have attempted to increase 
participation by linking the "donor card" in several ways with 
driver licensure; however, it does not appear that adequate 
studies of various methods — much less vigorous educational 
efforts — have been generally undertaken. If we are to move 
beyond the UAGA, I continue to believe that a pure form of 
"opting-^out" — rather than the proposal made in 1968 by Professors 
^Dukeminier and Sanders (279 New England J. Med. 413) , under which 
next-of-kin could also object to removal of the organ — would be 
the next best alternative. 

I urge you to lend your support to efforts bv private, 
state and federal groups to publicize the UAGA. so as 
to preserve the great ethical as well as social values 
in voluntary donation; if that is judged inadeouate to 
obtain needed organs for transplantation. I suggest the 
amendment of the UAGA to make "donation" automatic 
unless a person "opts out" during his or her lifetime. 



291 



3 . Inadequate Coordination 

The scarcity of organs makes them very dear; the burdens 
imposed in obtaining organs, including the burden of going to a 
grieving family to ask permission, increase the tendency to treat 
them as a resource of the local facility. Yet any limitations on 
the widest possible sharing of organs among transplant groups is 
medically unfortunate. Despite improved methods of fighting 
rejection, a better "tissue match" increases the likelihood of 
success, and the wider the pool of donors and recipients, the 
greater the likelihood of a good "match." ( See Attachment E.) 
Certainly, it contradicts notions of fairness as well as good 
sense when organ availability depends upon the ability of 
particular recipients or their family members to generate 
publicity for their plight; moreover, this spectacle — while 
serving a cathartic function for the public if someone comes 
forward with an organ to relieve a patient's desperate plight — is 
contrary to our usual proper norms of medical privacy and human 
dignity. 

Depending on logistical considerations, I believe that 
a regional or national system of organ transfers would 
be advisable, with support for local coordinators to 
facilitate donations . You should encourage 
surveillance and coordination by the CDC in this field. 

B. Live Donors 

The use of living donors raises a number of serious issues 
primarily centered around voluntary, informed consent ( see second 



-6- 



292 



part of Attachment D infra ) . The major issue needing continued 
attention is that of the participation of minors as donors 
(primarily of bone marrow) for their relatives. 

Another concern — the social expectation of privacy and 
voluntariness in organ donation — was drawn into question by a 
recent case in Iowa, in which a man with leukemia was attempting 
to learn from the state university hospital the identity of a 
woman whose tissue type was known by the hospital to be a good 
match for an experimental bone marrow graft to treat his 
leukemia. The Institutional Review Board had shown, in my view, 
appropriate sensitivity to the ethical questions in the way that 
it had permitted the physician-investigator to inquire in a 
nonspecific way whether the woman (who had been "typed" as part 
of an attempted treatment of her own child's leukemia) would be 
willing to consider donating bone marrow to patient-subjects in 
experimental treatments. It is regrettable that the trial judge, 
insisted that she be recontacted with the specifics of the 
instant patient's needs; the case is now on appeal. 

II. SCARITY: FUNDS 

The need for organs for transplantation makes this field 
somewhat unusual — but the expense of transplantation, like that 
of mechanical replacement for failed organs, raises questions 
that assert themselves with increasing urgency in the health 
arena. The ethical issues posed for public and private 
decisionmakers are those that arise whenever scarce funds are at 
issue, namely issues of obligation and of fairness. My two basic 



-7- 



293 



conclusions in this area are (1) that the issue is not how to 
avoid making difficult choices among people in need "but rather 
how to make such choices in a justifiable manner, and (2) that we 
must develop better means of determining how new medical 
developments relate to society's obligation to ensure equitable 
access to health care. 

&*- Making Choices 

A decade ago the federal government did an extraordinary 
thing: in the face of the suffering and death of a majority of 
the patients with end-stage renal disease (numbering in the 
thousands) who could not obtain treatment (principally, 
hemodialysis) that had already been shown effective in sustaining 
life and restoring "normal" functioning, Congress amended the 
Medicare law to guarantee federal funding of therapy for this.. 
single disease entity. (The Commission reviewed this history 
briefly, as an example of the theme of "limited resources" in its 
final report; see Attachment F.) 

What have we learned from this experience? First, that the 
predictions of the cost of such programs are very unreliable. 
While we ought not to overgeneralize from that experience — since 
the particular legislation was enacted without a detailed 
examination that might have produced somewhat more accurate 
forecasts of costs — we ought also not forget it. Demand tends to 
rise well above projections, particularly when medical and 
institutional prestige, and personal and corporate profits, are 
playing a role in determining "demand." 



294 

Second, and more important, we have learned that money is 
only briefly effective as a "cure" to relieve our collective 
discomfort over having to make moral choices, particularly 
choices that appear to be God-like: "who will live and who will 
die?" Although the funds are now available to treat chronic 
renal failure in any patient, physicians, nurses and health 
administrators must draw a line somewhere — not as the British 
health system does, based upon age, but upon a combination of 
factors. For example, in reporting last month on Deciding to 
Forego Life-Sustaining Treatment , the President's Commission 
stated that because the benefit to the patient would be so small, 
it would be "very hard to justify dialysis for a permanently 
unconscious patient who develops kidney failure" (p. 190) . 

Although the line of "no benefit" is a clear one, 
difficulties of choice persist when particular patients in need 
are indentif ied; it then becomes very difficult to deny any life- 
supporting treatment of possible benefit. But we must — and 
perhaps at the level of statistical risk and so forth, we will be 
able to — draw seme line, unless we are prepared to say patients 
are guaranteed access to any and all care they want, "need," or 
might possible profit from receiving. 
B. Equitable Access 

In addressing this issue of society's ethical obligation 
toward the health care of its members, the Commission determined 
that the standard of equity requires that everyone have access to 
an adequate level of care without the imposition of excessive 
burdens. Defining "adequacy" is clearly a difficult task, and to 



-9- 



295 



eliminate repetition, I have set forth the Commission's discus- 
sion of this point, in Securing Access to Health Care , as 
Attachment G to this statement. Of greatest relevance here are 
two points: first, while judgments about whether a particular 
treatment are not solely matters for professional judgment, 
expertise of the sort that the National Center for Health Care 
Technology (in HHS) was beginning to develop (regarding 
reimbursement under federal health care financing programs) 
certainly could be valuable; and second, since the greatest test 
of fairness will probably be "comparability," decisionmakers 
(particularly those who operate publicly, whose judgments are 
thus most likely to be treated as being generally applicable) 
must keep in mind the tendency of limited acts of generosity to 
have very broad ramifications. 

I urge that vou explore the ability of HHS to assess 
the relat ionship of particular treatments — not just 
organ transplantation — to the adequate level of health 
care that should be guaranteed by society to its 
x members in a manner that is fair and consistent. 



-10- 



296 

Capron 4/14/R3 

ATTACHMENT A 

Excerpts from 



Defining 
Death 



A Report on the 
Medical, Legal and 
Ethical Issues in the 
Determination of Death 



July 1981 



President's Commission for the Study of 
Ethical Problems in Medicine and 
Biomedical and Behavioral Research 



297 



Summary of 
Conclusions and 
Recommended Statute 



The enabling legislation for the President's Commis- 
sion directs it to study "the ethical and legal implications 
of the matter of defining death, including the advisability of 
developing a uniform definition of death." 1 In performing 
its mandate, the Commission has reached conclusions on a 
series of questions which are the subject of this Report. In 
summary, the central conclusions are: 

l.That recent developments in medical treatment ne- 
cessitate a restatement of the standards traditionally recog- 
nized for determining that death has occurred. 

2. That such a restatement ought preferably to be a mat- 
ter of statutory law. 

3. That such a statute ought to remain a matter for state 
law, with federal action at this time being limited to areas 
under current federal jurisdiction. 

4. That the statutory law ought to be uniform among the 
several states. 

5. That the "definition" contained in the statute ought 
to address general physiological standards rather than med- 
ical criteria and tests, which will change with advances in 
biomedical knowledge and refinements in technique. 

6. That death is a unitary phenomenon which can be ac- 
curately demonstrated either on the traditional grounds of 
irreversible cessation of heart and lung functions or on the 
basis of irreversible loss of all functions of the entire brain. 

7. That any statutory "definition" should be kept sepa- 
rate and distinct from provisions governing the donation of 
cadaver organs and from any legal rules on decisions to ter- 
minate life-sustaining treatment. 



M2U.S.C. §1802 (1978). 



298 
Defining Death 



To embody these conclusions in statutory form the 
Commission worked with the three organizations which 
had proposed model legislation on the subject, the Ameri- 
can Bar Association, the American Medical Association, 
and the National Conference of Commissioners on Uniform 
State Laws. These groups have now endorsed the following 
statute, in place of their previous proposals: 

Uniform Determination of Death Act 

An individual who has sustained either (1) irrevers- 
ible cessation of circulatory and respiratory functions, 
or (2) irreversible cessation of all functions of the en- 
tire brain, including the brain stem, is dead. A deter- 
mination of death must be made in accordance with 
accepted medical standards. 

The Commission recommends the adoption of this statute 
in all jurisdictions in the United States. 



299 

ATTACHMENT B 
Excerpts from 



Defining 
Death 



A Report on the 
Medical, Legal and 
Ethical Issues in the 
Determination of Death 



July 1981 



President's Commission for the Study of 
Ethical Problems in Medicine and 
Biomedical and Behavioral Research 



300 

60 Defining Death: Chapter 5 



Uniformity Among People and Situations: Besides 
moving slowly, the law ought to move evenhandedly. The 
statute ought not to reinforce the misimpression that there 
are different "kinds" of death, defined for different pur- 
poses, and hence that some people are "more dead" than 

others. , , . , ,, 

In many contexts, definitions are handmaidens to other 
purposes lawmakers are seeking to achieve Rather than 
askinc "what is death"? one might ask, "what difference 
does it make whether somebody is dead"?* That question 
has many answers, most of them familiar to everyone. Crim- 
inal law (murder v. aggravated assault), tort law (wrongful 
death), family law (the status of spouse and children), prop- 
erty and estate law, insurance law (payment of life insur- 
ance benefits and termination of health insurance pay- 
ments), and tax law, as well as some actions and culturally 
determined behaviors of family members, physicians, cler- 
ics and undertakers axe all initiated by the determination 
that a death has occurred. Were there good reason for one 
branch or another of the law or one or another cultural in- 
stitution to employ a different "definition" of death. logic 
would not preclude such a step. But in fact, society has 
found it desirable to employ a single standard for declaring 
death in all these circumstances and no special-purpose 
definitions have been seriously advanced. Calling the same 
person "dead" for one purpose and "alive" for another 
would engender nothing but confusion. 5 Thus in setting 
forth the law in statutory form, the wisest and most cau- 
tious course (furthering the principle of incrementalism as 
well) would be to adopt a rule recognizing the unity ot tne 
concept of death. Such a "definition" of death can be ap- 
plied in all appropriate circumstances; if a special need is 
identified for acting on a different basis, a separate 
status— other than that of being "dead"— could be defined 
for that purpose.* 



'Roger B. Dworkin. "Death in Context." 48 Ind. L. /. 623. 629 
(1973). 

'See, e.g. Fred Fabro. "Bacchiochi vs. Johnson Memorial Hospi- 
tal" 45 Conn. Med. 267 (1981) chronicling the troublesome case of 
Melanie Bacchiochi. On February 11. 1981 after repeated clinical 
examinations confirmed by electroencephalography, physicians 
found she had suffered irreversible loss of total brain function. 
Her physician was unwilling to remove her from the respirator be- 
cause of legal uncertainty since Connecticut's statute on "brain 
death" applies only to organ transplantation. "It is ironic that if 
the patient had been a donor, she could have been pronounced 
dead on February 11 and the respirator could have been with- 
drawn. Dead for transplantation, but not dead otherwise!" Id. at 
268. 

•Alexander M. Capron. "The Purpose of Death: A Reply to Profes- 
sor Dworkin," 48 Ind. L.J. 640, 643-45 (1973); Capron and Kass, 
op cit. at 107-08. 



301 

80 Defining Death: Chapter 5 



Finally, since the proposed statute is intended to apply 
in all situations, it ought not to be incorporated into a 
state's Uniform Anatomical Gift Act (UAGA). Placing it 
there would create the mistaken impression that a special 
"definition" of death needs to be applied to organ trans- 
plantation, which is not the case. (As a matter of fact, most 
of the respirator-supported cases in which the brain- 
oriented standard would be applicable are not potential do- 
nors, as noted in Chapter 2.) Section 7(b) of the UAGA 
makes the time of death a matter to be determined by the at- 
tending physician; the proposed Uniform Determination of 
Death Act specifies the grounds on which such a determi- 
nation are made. Some people have expressed concern that 
a determination of death in a potential organ donor might 
be made by a physician with a conflict of interest, but the 
UAGA specifies that the physician who determines that 
death has occurred "shall not participate in the procedures 
for removing or transplanting a part." 66 



* *- ■*- 



"Uniform Anatomical Gift Act § 7(b), 8 Uniform Laws Annot. 
608 (1972). 



23-029 0-83-20 



302 

A'ri.SCiii-Uiivt C 

Special Communication 

Guidelines for the Determination of Death 

Report ol the Medical Consultants on fhe Diagnosis ot Death to the President's Commission 
(or the Study ol Ethical Problems in Medicine and Biomedical and Behavioral Research 



The Guidelines set forth in this report repiesent the views ol the signatories is individuals, 
they do not necessarily lellecl the policy ot any institution or prolessional association with which 
any signatory is all.lialed Alihough the practice ol individual signatories may vary sightly, 
s.gnaioi.es ag.ee on Ihe acceptability ol these guidelines Jesse Barbei. MD Don Becker. MO. 
R.chaid Behrman. MD. JD. Donald R Benne'l MD. R.chaid Be.eslord. MD. JD. Reginald 
B.cktord MD. William A Black, Jr. MD. Ben.em.n Boshes. MD. PhD. Philip Praunsie.n. MD. John 
Bu..oughs. MD. JD Russell Butler. MD. John Ca.onna. MD. Shelley Chou, MD. PhD Kemp Clark. 
MD Ronald C.anlord MD Michael Earnest MD. Aloert Ehle MD. Jack M Fein. MD. Sal Fiscma. 
MD JD. Terrance G Furlow. MD. JD. Eli Goldensohn. MD: Jack G.abow MD. Phillip M Gieen. 
MD. A«e Gren.ik MD. Charles E Henry. PhD. John Huphes. MD. PhD DM Howard Kaulman. MD. 
Robert King MD Julius Kore.n. MD. Thomas W Langlitl. MD Cesare lombroso. MD Kevin M 
Mclniyre MD JD Richard L Maslend MD. Don Harper Mills MD JD Gaelano Mol.nar. MD. 
By. on C Pevehouse. MD. Lawrence H Pills. MD. A Bernard Pleel. MD. Fred Plum, MD. Jerome 
Posner. MD. Dav.d Powner. MD. Richard Rovil. MD. Peler Salar. MD. Henry Sch.am. MD. 
Edward Schlesmger MD Roy Selby. MD James Snyder. MD. Bruce F Sorenson. MD: Cary 
Suler. MD. Barry Tha.p, MD. Fernando Torres. MD. A Earl Walker. MD. Arthur Ward. MD: Jack 
Whisnant MD. Robert W.lkus MD. and Harry Zimmerman. MD 

The p.epaianon ol this report was facilitated by Ihe Presidents Commission bul Ihe 
guidelines have nol been passed on by Ihe Commission and are nol inlended as mailers lor 
governmental review or adoption. . 



THE ADVENT of effective artificial 
cardiopulmonary support for severely 
brain-injured persons has created 
some confusion during the past sev- 
eral decades about the determination 
of death. Previously, loss of heart and 
lung functions was an easily observ- 
able and sufficient basis for diagnos- 
ing death, whether the initial failure 
occurred in the brain, the heart and 
lungs, or elsewhere in the body. Irre- 

For editorial comment 
see p 2194. 

versible failure of either the heart 
and lungs or the brain precluded the 
continued functioning of the other. 
Now, however, circulation and respi- 
ration can be maintained by means of 
a mechanical respirator and other 
medical interventions, despite a loss 
of all brain functions. In these cir- 
cumstances, we recognize as dead an 
individual whose loss of brain func- 
tions is complete and irreversible. 

Repnnl reouesls to Joanne Lynn. MD. Assistant 
Dneclor lo. Med.cal Slud.es, President's Commis- 
sion tor Ihe Study ol Ethical Problems in Medicine 
and Biomedical end Behavioial Research. Suile 
665. ?000 K St NW. Washington. DC ?O006 



To recognize reliably that death 
has occurred, accurate criteria must 
be available for physicians' use. These 
now fall into two groups, to be applied 
depending on the clinical situation. 
When respiration and circulation 
have irreversibly ceased, there is no 
need to assess brain functions di- 
rectly. When cardiopulmonary func- 
tions are artificially maintained, neu- 
rological criteria must be used to 
assess whether brain functions have 
ceased irreversibly. 

More than half of the states now 
recognize, through statutes or judicial 
decisions, that death may be deter- 
mined on the basis of irreversible 
cessation of all functions of the brain. 
Law in the remaining states has not 
yet departed from the older, common- 
law view that death has not occurred 
until "all vital functions" (whether or 
not artificially maintained) have 
ceased. The language of the statutes 
has not been uniform from state to 
state, and the diversity of proposed 
and enacted laws has created sub- 
stantial confusion. Consequently, the 
American Bar Association, the Amer- 
ican Medical Association, the Na- 



2184 JAMA. Nov 13. 1981— Vol 246. No. 19 



tional Conference of Commissioners 
on Uniform State Laws, and the Pres- 
ident's Commission for the Study of 
Ethical Problems in Medicine and 
Biomedical and Behavioral Research 
have proposed the following model 
statute, intended for adoption in 
every jurisdiction: 

UNIFORM DETERMINATION OF 

DEATH ACT 
An individual who has sustained either 
(II irreversible cessation of circulatory 
and respiratory functions, or (2) irrevers- 
ible cessation of all functions of the entire 
brain, including the brain stem, is dead. A 
determination of death musl be made i' 
accordance wilh accepted medical stai. 
dards. 

This wording has also been endorsed 
by the American Academy of Neurol- 
ogy and the American Electroen- 
cephalographic Society. 

The statute relies on the existence 
of "accepted medical standards" for 
determining that death has occurred. 
The medical profession, based on 
carefully conducted research and ex- 
tensive clinical experience, has found 
that death can be determined reliably 
by either cardiopulmonary or neuro- 
logical criteria. The tests used for 
determining cessation of brain func- 
tions have changed and will continue 
to do so with the advent of new 
research and technologies The "Har- 
vard criteria" (JAMA 1908,205:337- 
340) are widely accepted, but ad- 
vances in recent years have led to the 
proposal of other criteria. As an aid 
to the implementation of the pro- 
posed uniform statute, we provide 
here one statement of currently 
accepted medical standards. 

INTRODUCTION 

The criteria that physicians use in 

Diagnosis ot Death 



303 



determining that death has occurred 
should (I) eliminate errors in classi- 
fying a living individual as dead; (2) 
alio* as few errors as possible in 
classifying a dead body as alive; (3) 
allow a determination to be made 
without unreasonable delay; (4) be 
adaptable to a variety of clinical 
situations; and (5) be explicit and 
accessible to verification. 

Because it would be undesirable for 
any guidelines to be mandated by 
legislation or regulation or to be 
inflexibly established in case law, the 
proposed Uniform Determination of 
Death Act appropriately specifies 
only "accepted medical standards." 
Local, state, and national institutions 
and professional organizations arc 
.encouraged to examine and publish 
their practices. 

The following guidelines represent 
a distillation of current practice in 
regard to the determination of death. 
Only the most commonly available 
and verified tests have been included. 
The time of death recorded on a death 
certificate is at present a matter of 
local practice and is not covered in 
this document. 

These guidelines are advisory. 
Their successful use requires a com- 
petent and judicious physician, expe- 
rienced in clinical examination and 
the relevant procedures All periods 
of observation listed in these guide- 
lines require the patient to be under 
the care of a physician. Considering 
the responsibility entailed in the 
determination of death, consultation 
is recommended when appropriate. 

The outline of the criteria is set 
forth below in boldface letters. The 
lightface text that follows each head- 
ing explains its meaning In addition, 
the two sets of criteria (cardiopulmo- 
nary and neurological) are followed 
by a presentation of the major com- 
plicating conditions: drug and meta- 
bolic intoxication, hypothermia, 
young age, and shock. It is of para- 
mount importance that anyone refer- 
ring to these guidelines be thoroughly 
familiar with the entire document, 
including explanatory notes and com- 
plicating conditions. 

THE CRITERIA 
FOR DETERMINATION OF DEATH 

An individual presenting the find- 
ings in cifhvr section A (cardiopulmo- 
nary) or section B (neurological) is 



dead In either section, a diagnosis of 
death requires that both cessation of 
functions , as set forth in subsection 1, 
and ir reversibility , as set forth in 
subsection 2, be demonstrated. 

A. An individual with irreversible ces- 
sation of circulatory and respiratory 
functions is dead. 

I. Cessation is recognized by an 
appropriate clinical examination. 

Clinical examination will disclose 
at least the absence of responsive- 
ness, heartbeat, and respiratory ef- 
fort. Medical circumstances may re- 
quire the use of confirmatory tests, 
such as an ECG. 

2. lrrc\erstbitity is recognized b\ per- 
sistent cessation of functions during an 
appropriate period of observation and/or 
trial of therapy. 

In clinical situations where death is 
expected, where the course has been 
gradual, and where irregular agonal 
respiration or heartbeat finally 
ceases, the period of observation fol- 
lowing the cessation may be only the 
few minutes required to complete the 
examination. Similarly, if resuscita- 
tion is not undertaken and ventricu- 
lar fibrillation and standstill develop 
in a monitored patient, the required 
period of observation thereafter may 
be as short as a few mintues. When a 
possible death is unobserved, unex- 
pected, or sudden, the examination 
may need to be more detailed and 
repeated over a longer period, while 
appropriate resuscitative effort is 
maintained as a test of cardiovascular 
responsiveness. Diagnosis in individu- 
als who are first observed with rigor 
mortis or putrefaction may require 
only the observation period necessary 
to establish that fact. 

B. An individual v»iih irreversible ces- 
sation of all functions of the entire brain, 
including the brain stem, is dead. The 
"functions of the entire brain" that 
are relevant to the diagnosis are 
those that are clinically ascertain- 
able. Where indicated, the clinical 
diagnosis is subject to confirmation 
by laboratory tests, as described in 
the following portions of the text. 
Consultation with a physician experi- 
enced in this diagnosis is advisable. 

1. Cessation is recognized when evalu- 
ation discloses findings of a and b: 

s. Cerebral functions arc absent, and 

There must be deep coma, that is, 
cerebral unreceptivily and unrespon- 



sivity. Medical circumstanres may 
require the use of confirmatory stud- 
ies such as an EEC or blood-flow 
study. 

b. brain stem functions are absent. 
Reliable testing of brain stem re- 
flexes requires a perceptive and expe- 
rienced physician using adequate 
stimuli. Pupillary light, corneal, ocu- 
locephalic, oculovestibular, oropha- 
ryngeal, and respiratory (apnea) re- 
flexes should be tested. When these 
reflexes cannot be adequately as- 
sessed, confirmatory tests are recom- 
mended. 

Adequate testing for apnea is very 
important. An accepted method is 
ventilation with pure oxygen or an 
oxygen and carbon dioxide mixture 
for ten minutes before withdrawal of 
the ventilator, followed by passive 
flow of oxygen. (This procedure 
allows PaCO- to rise without hazard- 
ous hypoxia.) Hypercarbia adequately 
stimulates respiratory effort within 
30 seconds when Paco ; is greater than 
60 mm Hg. A ten-minute period of 
apnea is usually sufficient to attain 
this level of hypercarbia. Testing of 
arterial blood gases can be used to 
confirm this level. Spontaneous 
breathing efforts indicate that part of 
the brain stem is functioning. 

Peripheral nervous system activity 
and spinal cord reflexes may persist 
after death. True decerebrate or 
decorticate posturing or seizures are 
inconsistent with the diagnosis of 
death. 

2. IrrcMTsibilily is recognized when 
evaluation discloses findings of a and b 
and c: 

a. The cause of coma is established 
and is sufficient to account for the loss of 
brain functions, and . . . 

Most difficulties with the determi- 
nation of death on the basis of neuro- 
logical criteria have resulted from 
inadequate attention to this basic 
diagnostic prerequisite. In addition to 
a careful clinical examination and 
investigation of history, relevant 
knowledge of causation may be 
acquired by computed tomographic 
scan, measurement of core tempera- 
ture, drug screening, ERG, angiogra- 
phy, or other procedures. 

b. Ihr possibility of recovery of any 
brain functions is excluded, and . . . 

The most important reversible con- 
ditions are sedation, hypothermia, 
neuromuscular blockade, and shock. 



JAMA. Nov 13. 1981— Vol 246. No 19 



Diagnosis ot Death 2185 



304 



In I he unusual circumstance where a 
sulliiirnt ransr rannot be estab- 
lished, irreversibility ran lie reliably 
inferred only afler extensive evalua- 
tion for ilrui! intoxication, extended 
observation, and other testing A 
determination that blood flow to the 
brain is absent can be used to demon- 
strate a sufficient and irreversible 
condition. 

c. the cessation of all brain functions 
persists for an appropriate period of 
oh-cnatinn and/or trial of therapy. 

Even when coma is known to have 
started at an earlier time, the absence 
of all brain functions must be estab- 
lished by an experienced physician 
at the initiation of the observation 
period. The duration of observation 
periods is a matter of clinical judg- 
ment, and some physicians recom- 
mend shorter or longer periods than 
those niven here. 

Except for patients with drug 
intoxication, hypothermia, young age, 
or shock, medical centers with sub- 
stantial experience in diagnosing 
death neurologically report no eases 
of brain functions returning following 
a six-hour cessation, documented by 
clinical examination and confirmato- 
ry EEC. In the absence of confirma- 
tory tests, a period of observation of 
at least 12 hours is recommended 
when an irreversible condition is well 
established. For anoxic brain damage 
where the extent of damage is more 
difficult to ascertain, observation for 
2J hours is generally desirable. In 
anoxic injury, the observation period 
may be reduced if a test shows cessa- 
tion of cerebral blood flow or if an 
EEG shows electrocerebral silence in 
an adult patient without drug intoxi- 
cation, hypothermia, or shock. 

Confirmation of clinical findings by 
EEG is desirable when objective doc- 
umentation is needed to substantiate 
the clinical findings. Electrocerebral 
silence verifies irreversible loss of 
cortical functions, except in patients 
with drug intoxication or hypother- 
mia. (Important technical details are 
provided in "Minimal Technical Stan- 
dards for EEG Recording in Sus- 
pected Cerebral Death" [Guidelines in 
EEG 19ltn. Atlanta, American Elec- 
troencephalograph'^ Society, 1980. 
section 4, pp 19-2-1].) When joined 
with the clinical findings of absent 
brain stem functions, electrocerebral 
silence confirms the diagnosis. 

2186 JAMA. Nov 13. 1981-Vol 246. No. IB 



Complete cessation of circulation to 
the normnthrrmir adult brain for 
more than ten minutes is incompati- 
ble with survival of brain tissue. 
Documentation of this circulatory 
failure is therefore evidence of death 
of the entire brain. Knur- vessel intra- 
cranial angiography is definitive for 
diagnosing cessation of circulation to 
the entire brain (both cerebrum and 
posterior fossa) but entails substan- 
tial practical difficulties and risks. 
Tests are available that assess circu- 
lation only in the cerebral hemi- 
spheres, namely radioisotope bolus 
cerebral angiography and gamma 
camera imaging with radioisotope 
cerebral angiography. Without com- 
plicating conditions, absent cerebral 
blood flow as measured by these tests, 
in conjunction with the clinical deter- 
mination of cessation of all brain 
functions for at least six hours, is 
diagnostic of death. 

COMPLICATING CONDITIONS 
A. Drug and Metabolic Intoxication. — 
Drug intoxication is the most serious 
problem in the determination of 
death, especially when multiple drugs 
are used. Cessation of brain functions 
caused by the sedative and anesthetic 
drugs, such as barbiturates, benzodi- 
azepines, meprobamate, methaqua- 
lone, and trichloroethylene, may be 
completely reversible even though 
they produce clinical cessation of 
brain functions and electrocerebral 
silence. In cases where there is any 
likelihood of sedative presence, toxi- 
cology screening for all likely drugs is 
required. If exogenous intoxication is 
found, death may not be declared 
until the intoxicant is metabolized or 
intracranial circulation is tested and 
found to have ceased. 

Total paralysis may cause unre- 
sponsiveness, areflexia. and apnea 
that closely simulates death. Expo- 
sure to drugs such as neuromuscular 
blocking agents or aminoglycoside 
antibiotics, and diseases like my- 
• asthenia gravis are usually apparent 
by careful review of the history- P r0 " 
longed paralysis after use of succinyl- 
choline chloride and related drugs 
requires evaluation for pseudocholin- 
esterase deficiency. If there is any 
question, low-dose atropine stimula- 
tion, electromyogram. peripheral 
nerve stimulation, EEG, tests of 
intracranial circulation, or extended 



observation, as indicated, will make 
the diagnosis clear. 

In drug-induced rnma, EEG arl"i- 
ly may return or persist while > 
patient remains unresponsive, nnd 
therefor.' the EEG may be an impor- 
tant evaluation along with extended 
observation. If the EEG shows elec- 
trocerebral silence, short latency au- 
dilory or somnloscnsory-cvokcd po- 
tentials may be used to test brain 
stem functions, since these potentials 
are unlikely In he affected by drugs. 

Some severe illnesses (eg, hepatic 
encephalopathy, hyperosmolar coma, 
and preterminal uremia) ran cause 
deep coma. Before irreversible cessa- 
tion of brain functions can be deter- 
mined, metabolic abnormalities 
should be considered and, if possible, 
corrected. Confirmatory tests of cir- 
culation or EEG may be necessary. 

B. Hypothermia.— Criteria for reli- 
able recognition of death are not 
available in the presence of hypother- 
mia (below 32.2 °C core temperature). 
The variables of cerebral circulation 
in hypothermic patients are not suffi- 
ciently well studied to know whether 
tests of absent or diminished circula- 
tion are confirmatory. Hypothe- 
can mimic brain death by ordi. 
clinical criteria and can protect 
against neurological damage due to 
hypoxia. Further complications arise 
since hypothermia also usually pre- 
cedes and follows death. If these 
complicating factors make it unclear 
whether an individual is alive, the 
only available measure to resolve the 
issue is to restore normolhermia. 
Hypothermia is not a common cause 
of difficulty in the determination of 
death. 

C. Children.— The brains of infants 
and young children have increased 
resistance to damage and may recover 
substantial functions even after ex- 
hibiting unresponsiveness on neuro- 
logical examination for longer periods 
compared with adults. Physicians 
should be particularly cautious in 
applying neurological criteria to de- 
termine death in children younger 
than 5 years. 

D. Shock.— Physicians should also 
be particularly cautious in applying 
neurological criteria to determine 
death in patients in shock becau; )e 
reduction in cerebral circulation ^an 
render clinical examination and labo- 
ratory tests unreliable. 

Diagnosis of Death 



305 



5di5t'oiriaIls 



Epidermolysis Bullosa Research Association Guidelines for the Determination of Death 



Voluntary health associations have made enormous contribu- 
tions to the control of many major diseases The National 
Tuberculosis Association (NTA). established in I90V was one 
of the first to be organized, and others that followed patterned 
their organisational structure and activities after the NTA. The 
major strength of voluntary health groups is the cooperative 
effort and understanding they create between physicians and 
lav persons who together share responsibilities on governing 
boards and committees. 

The main activities of volunrary health associations are 
support of research, public education service to patients, 
support of professional education, and advice ro government 
on legislation and reputation The control of tuberculosis and 
the conquest of poliomyelitis, advances in the prevention and 
tieatment of heart disease, and the success of renal dialysis and 
transplantation are examples of what can be accomplished by 
voluntary health agencies. These successes have served to 
encourage the formation of other groups whose members have 
a special concern for a disease that has afflicted a family 
member or friend. Most of the voluntary health groups 
organized in recent years have been small in size and have 
directed theit attention to relatively uncommon diseases. These 
otganizations face an uphill battle for recognition, are unable to 
raise large sums of money to support their activities, and often 
are battling against diseases that will not yield to current 
research technology. Ofien, however, the greater the challenge, 
the greater the enthusiasm of those who are being challenged. 
A recent addition to the voluntary health movement is the 
Epidermolysis Bullosa Research Association. Although the 
prevalence of epidermolysis bullosa in the United States is not 
precisely known, the new association has identified more than 
1.500 cases and believes that through increased research this 
distressing disorder may either be prevenred or more defini- 
tively treated. Epidermolysis bullosa is a group of inherited skin 
disorders, characterized by the formation of blisters that follow 
mild trauma. The genetic basis for these disorders make them a 
lifelong problem for those unfortunate enough to inherit the 
disorder. Like other chronic diseases, it arouses greater concern 
and interest in the establishment of a society than do acute 
self-limited diseases. 

The Epidermolysis Bullosa Research Association is interested 
in receiving reports of research on epidermolysis bullosa, in 
recruiting both lay and medical professionals to its ranks, and, 
of course, in receiving donations to advance its cause. 
Interested persons should contact the executive director of the 
association at 29V> Avenue W. Brooklyn, NY 11229- 

U pi Haw R BaHCLAV. MD 



Add'esi atMonat communication* to Ihe Editor. S35 N Dearborn Si. 
CnicaQO. H. 6O810. 



The report on Guidelines for the Determination of Death*" in 
this issue (p 21H4) is a landmark document with far-reaching 
medical, ethical, and legal implications. It is a summary of 
currently accepted medical practices for the determination of 
death, both cardiorespiratory and neurological, although the 
majority of the report is devoted to the diagnosis of 
neurological, or brain, death Physicians from numerous 
specialities contributed to the drafting of this report, which was 
coordinated by the stalT of the President's Commission for the 
Study of Ethical Problems in Medicine and Biomedical and 
Behavioral Research. These guidelines are included as an 
appendix to the more comprehensive report by the President s 
Commission on "Defining Death: A Report on the Medical. 
Legal and Ethical Issues in the Determination of Death" (this 
entire report was approved by the President's Commission and 
sent to the President on July 9. 1981). 

Until now, the most widely accepted standards for brain 
death in the United States have been the criteria developed by 
the Ad Hoc Committee of the Harvard Medical School to 
Examine the Definition of Brain Death, published in JAMA in 
196S (205.337-340). These new guidelines are an update of 
currently accepted standards in the light of a gieat body of 
clinical experience accumulated since the original report of the 
Harvard Committee, and the development and refinement of 
new technologies in the laboratory confirmation of the 
diagnosis. 

This report is important primarily because so many physi- 
cians were able to reach a consensus on a common set of 
guidelines, even though there were (and still are) differences of 
opinion on specific aspects of the criteria, and the signatories 
were aware of the ethical and legal implications of developing a 
set of national standards For this many prnsioans from the 
fields of neurology, neurosurgery, electroencephalography, 
critical care medicine, anesthesiology, and legal medicine to 
reach a consensus is truly a remarkable achievement, of which 
the medical profession can be proud. Efforts such as this 
suggest that physicians have recognized the need fot coopera- 
tion in developing standards in areas of controversy. In the next 
few decades, it will become more apparent to the medical 
community that it will need to take positions on even more 
controversial issues Future statements will cover such areas as 
organ donation, "do not resuscitate" orders, and guidelines for 
the termination of treatment of "hopelessly ill" patients. 

This report is not the final word on standards for 
determining death, but it is an important step forward in 
society's attempts to deal with bioethical dilemmas brought 
about by advances in medical technology, and it further 
reinforces the view that the medical profession must and will 
continue to assume a leadership role in these endeavors. 

VX'ntiAM R Baici-ay. MD 



2194 JAMA. Now 13. 1981— Vol 246. No. 19 



Editorials 



306 

ATTACHMENT D 
Excerpts from 



Catastrophic Diseases: 
Who Decides What? 



A Psychosocial and Legal A nalysis 

of the Problems Posed by Hemodialysis 

and Organ Transplantation 



Jay Katz and Alexander Morgan Capron 



Russell Sage Foundation New York 



1975 



307 

196 Stages of Decisionmaking 

* * + 



4. Selection of Donors 

One resource for the modern treatment of the catastrophic illnesses dis- 
cussed here is unique: organs for transplantation. Since this resource is so 
unusual, we have chosen to treat it separately from the discussion of those 
resources (including artificial organs) whose supply is largely dependent 
on economic factors. We begin with a discussion of formulating policy on 
how to obtain organs (which is brief in light of the similarity of the issues 
to the questions discussed concerning the distribution of resources); this is 
followed by sections in which donations from living and dead persons are 
discussed. 

a. Policies on Obtaining Organs. As is true for other resources, the cen- 
tral fact about transplantable organs is their scarcity. Consequently, well 
thought-out policies are required to increase the supply. The least expensive 
and most readily available sources consists of cadaver organs, primarily 
from accident victims." 9 

Prior to 1968, organ donation in this country was complicated by anach- 
ronistic legal provisions designed to prohibit graverobbing and by the 
absence of clear rules specifying the interests which could exist in a dead 
body and who could exercise them. The promulgation of the Uniform 
Anatomical Gift Act (UAGA) in the summer of 1968, and its subsequent 
adoption by all states and the District of Columbia, went a long way 
to cut through the fog which had enshrouded the subject. Under the Act, 
a person has the right during his lifetime to permit or forbid the use of his 
organs for purposes of treatment, research, and teaching after his death; 
if he fails to act, the organs can be donated by his next-of-kin (according 
to an order of priority established by the Act) after the person has died. 
The donee can be an individual patient or a physician or hospital, with the 
latter being free to use the organs as needed locally or elsewhere." 



88 See, e.g., Dukcminicr, Supplying Organs for Transplantation, 68 Mich. L. Rev. 
811, 814-15 (1970) — citing statistics that 10,000 kidney transplants could be per- 
formed per year in this country if immunological problems are solved, and that 
there are approximately 10,600 suitable cadaver kidneys available each year. 

80 Thus, the organ-typing and patient-matching program operated for kidneys by 
Dr. Paul Terasaki's group at U.C.L.A. provides for hospitals to share the kidneys 
available to them on a nationwide basis, for which they receive "credits" that put 
them higher on the list for a cadaver organ the next time a "compatible" one is 
nvailable. See Terasaki, Wilkinson Sc McClelland, National Transplant Communica- 



308 



Formulation of Policy 197 

In effect, the UAGA creates a "market" system with a zero price tor 
organs (although the donee, by custom or contract, sometimes pays the 
cost of the donor's final hospitalization as well as the expense of removing 
the organ). The system relies on individual choice, with a leading role 
being taken by physicians who in most circumstances are the initiators of 
the donation. While no reliable figures arc yet available to establish the 
impact the UAGA has had on the level of donation, it is generally agreed 
that not enough organs are being donated to meet present need, and some 
commentators doubt that the current method will ever produce sufficient 
donations. 00 

In its place a number of alternatives are possible. The first would simply 
add a payment procedure to UAGA-type organ transfers. Although the 
Act speaks of "donations," its terms do not prohibit sales as well. It is un- 
certain, however, that individuals would express much interest in an offer 
to sell a right to one's organs after death (with present payments), since 
the purchaser would have little assurance that the.seller would die at a time 
and place or in a manner conducive to useful organ donation." 1 It would 
be possible, however, to make payment to a terminally ill patient, or, after 
his death, to his estate. Sales of this type might, however, pose serious 
psychological threats for dying patients and impose unwanted pressures on 
the next-of-kin. 

The sale of "spare" organs by living donors for immediate delivery raises 
fewer logistical and psychological problems. Jesse Dukeminier, Jr., found 
"no statute in an American state expressly prohibiting the sale of a spare 
organ" 02 but nevertheless suggested that making a payment to a live donor 
raises the prospect of civil and criminal liability for the physician removing 
the organ. While we do not share his concern on these points, we doubt 
that payment is wise for policy reasons. As Richard M. Titmuss has argued 
with considerable force, a major fault with the American system of collect- 
ing blood is that the existence of paid donors discourages volunteers.* 3 
While all the data necessary to support his argument are not available, the 

tions Network, 218 J. A.M. A. 1674 (1971). This type of arrangement is discussed in 
greater detail in Chapter Nine. 

9n See, e.g., Sanders & Dukeminier, note 53 supra, at 394 ff.\ Note. Compulsory 
Removal of Cadaver Organs, 69 Colum. L. Rev. 693 (1969) [hereinafter cited as 
Compulsory Removal]. 

01 If the purchaser is the state (or other national organization) the prpblem of 
location is reduced somewhat. Were A to buy the right to fl's organs at the time of 
the latter's demise, A would not want B to die in a distant city where his organs 
would do A no good. Were the government to purchase the organs, it might be less 
concerned, since they could probably be put to use in any of a number of locations. 

82 Dukeminier, note 88 supra, at 850. 

» 3 R. Titmuss. The Gift Relationship: From Human Blood to Social Pouar 
(1971). 



309 

198 

Stages of Decisionmaking 

danger that payment for organs (kidneys in particular) would decrease 
"altruism" among donors and their next-of-kin is one reason for not per- 
mitting payment for organs. * Furthermore, since the poor would probably 
sell organs disproportionately, this system would probably be subject to a 
charge of "exploitation." 

An alternative which is likely to increase the supply would be to presume 
that organs may be removed from any corpse unless a prior objection has 
been raised. In the proposal made by Dukeminier and Sanders," objection 
could be raised "either by the decedent during his life or by his next-of-kin 
after the decedent's death."" Giving a role to the relatives is intended to 
permit them to protect their religious beliefs and is also a recognition that 
most transplanters would hesitate to go ahead if relatives were to claim that 
the deceased objected to the removal of his organs— even if they could 
produce no "proof" of this fact within the short time in which organs 
remain "viable" after a person's death. Yet as others have noted, by requir- 
ing the transplanters to make sure that the relatives do not object, the 
Dukeminier-Sanders plan places as much of a burden (in terms of effort to 
secure consent and danger of delay) on the system as the existing pro- 
cedure. 87 The debate thus turns on whether society would find a system 
of choosing to give ("opting-in") or choosing not to give ("opting-out") 
more acceptable. 

If the right to object were to be left solely with the person whose organs 
are to be removed, the process of obtaining organs could be greatly simpli- 
fied and the number of available organs would doubtless increase greatly. 
The presumption in favor of routine salvaging would have to be widely 
publicized and "opting-out" made as simple as sending a preaddressed post- 
card to a central computer registry which could be consulted by a surgeon 
prior to organ removal." Before the enactment of the UAGA, questions 

"If the government purchases the organs, would it do so in every case (at a high 
cost in resources thus diverted from lifesaving therapy)? If not, on what basis would 
it decide when to pay and when not? (If on the basis of wealth of the corpse, why 
not employ more direct means of income redistribution?) If individuals were to buy 
the organs, it would amount to the creation of a market system on the distribution 
side, with all the problems discussed earlier in subsection 3(c)[i]. 

" See Sanders & Dukeminier, note 53 supra, at 410-13; Dukeminier, note 88 supra, 
at 837-42; Dukeminier & Sanders, Organ Transplantation: A Proposal for Routine 
Salvaging of Cadaver Organs, 279 New Eno. J. Med. 413 (1968). 

89 Dukeminier, note 88 supra, at 837. 

"Sadler, Sadler. Stason & Stickcl: Transplantation: A Case for Consent, 280 
New Eno. J. Med. 862 (1969). 

" A central renal registry was part of a plan, along the lines outlined here, pro- 
posed by the Advisory Oroup on Transplantation Problems appointed by the Health 
Minister* in Great Britain and chaired by Sir Hector MacLennan, M.D. See Advice 



310 



Formulation of Policy 199 

might have arisen whether such an arrangement would give sufficient atten- 
tion to the next-of-kin's rights over the corpse. The UAGA made clear, 
however, that these rights, if they ever existed, are subject to alteration or 
abolition by the legislature; the decedent's determination to give his organs 
for transplantation or other use is binding, despite any objection on the 
part of his relatives. It seems equally valid to reduce relatives' control so 
as to permit removal of the organs unless a deceased had objected. A more 
difficult question is raised if the relatives claim an objection on religious 
grounds. On the one hand, the deceased was in a position to forbid use of 
his body if he shared his relatives' view. On the other hand, the relatives 
may claim that their religion does not make requirements about the burial 
of one's own body but about those of one's kin. This argument may prove 
too much, however. On this logic, could not the relatives equally well claim 
a "right" to control any body, whether the deceased be a relative or a 
member of their church or not? 89 

A more far-reaching restriction on the right to object could abolish this 
right altogether, making donation compulsory, 100 as autopsies already are 
under certain conditions. 101 

Moreover, if organs are treated as property of the decedent, the decedent 
may have no power to order destruction of his organs by burial or cremation 
so long as the organs have value. It has been held in a number of cases that 
a direction to destroy one's own property at death is against public policy 
and is therefore void. 102 

While these and other analogies suggest that the public interest in saving 
lives through transplantation is great enough to justify making organ re- 
moval automatic (when medically useful), the policy issues (such as impact 
of this method on the emotions and personal feelings of the survivors) 
need to be openly debated before legislatures take such a step. Furthermore, 
since the donor is also deprived of the right to object, the religious con- 
siderations mentioned previously would loom much larger. If it is possible 
for the government to "accommodate its purpose [i.e., saving lives] by 



on the Question of Amending the Human Tissue Act 1961 (Cmnd. 4106) National 
Health Servjte (1969). Their recommendations were embodied in a Renal Trans- 
plant Bill, which was not ndopted. 

" 9 If the deceased had been a member of their church, he could have chosen to 
"opt-out" of donation himself. 

100 See Compulsory Removal, note 90 supra. 

101 See, e.g., Young v. College of Physicians & Surgeons, 81 Md. 358, 32 A. 177 
(1895); Sturgeon v. Crosby Mortuary, Inc., 140 Neb. 82, 299 N.W. 378 (1941). 

102 Dukeminier, note 88 supra, 834. ■ 



311 



Stages of Decisionmaking 
means which do not impose such a burden," 103 then compulsory removal 
of cadaver organs would ran afoul of the First Amendment. 

The only way to establish the need for a compulsory system, in other 
words, is to try less restrictive systems and see if they will produce an ade- 
quate supply. We believe that, for the moment, present policy, as embodied 
in the Uniform Anatomical Gift Act, ought to be given a fair trial first. 
Studies should, however, be conducted to determine whether the Act is 
adequately facilitating donations and whether any of its features should 
be revised. The real need for a change in policy on the obtaining of organs 
will arise when and if transplantation technology overcomes the problem 
of rejection and establishes itself as a highly successful form of therapy. 
If, under these circumstances, it appears that a change in procedure is 
warranted, prime consideration should be given to the "opting-out" system 
proposed by the MacLennan committee in Great Britain. 104 While it might 
be objected that in the case of a patient who had not opted-out, the attend- 
ing physician would feel unwarranted pressure to forego necessary treat- 
ment so as to speed death, it seems likely that the very much greater supply 
of organs that could be expected under such a system would on the whole 
reduce the pressure in each individual case. 

b. Donation by Living Individuals. Thus far the policies under discussion 
have been ones which require a societal judgment, and we have spoken in 
terms of legislative action. As we turn now to issues that have been dealt 
with largely through the private ordering of physicians, hospitals, patients, 
donors, and their families, the question arises whether a need exists for 
more broadly representative groups to engage in formulating policy more 
openly and explicitly. The following discussion will treat separately the do- 
nation of paired and unpaired organs, with primary attention devoted to 
the formulation of policies concerning the former. 

i. paired organs. As described in Chapter Four, living donors have 
been an important source of kidneys for transplantation since the earliest 
days of the procedure. Patients' relatives were the donors in more than 30 
percent of all kidney grafts to date and they continue to provide an impor- 
tant source of organs. Unrelated living donors, by contrast, gave 14.5 per- 
cent of the kidneys in the 14 years prior to 1967 for which records are 
available, but have not been used as donors at all since 1969. 105 Since the 

103 Braunficld v. Brown, 366 U.S. 599, 607 (1961). 

104 See note 98 supra. 

10 *See Advisory Committee to the Renal Transplant Registry, Ninth Report of 
the Human Renal Transplant Registry, 220 J.A.M.A. 253 (1972). In addition to the 
122 organs included in this figure for 1953-1966, and 144 to date, there have been 
to date 31 donations by spouses, who are also "unrelated" in the genetic sense. On 
the other hand, Dr. Carl Fellner concludes on the basis of the early reports (which 
contained a finer breakdown of donor categories) that more than half of the kidneyi 



312 



Formulation of Policy 201 

failure to employ this source does not stem from any ready availability 
of organs from other sources (as has already been noted), it must be a 
result of transplant surgeons' choice — and, in fact, this situation provides 
a valuable illustration of policymaking by physicians. 

The reasons physicians have difficulties in using unrelated donors are not 
hard to fathom. Outside of research settings, physicians are not used to 
dealing with persons who will derive no therapeutic benefit from an inter- 
vention. Although some transplanters made use of live, unrelated donors 
in the early days of renal grafting, perhaps because less was known about 
how to keep cadaver organs viable and because the experimental nature of 
the procedure meant that all (recipients as well as donors) were taking 
risks, gradually there emerged a "distrust and suspicion toward the moti- 
vation of such [unrelated live] donors and a definite repugnance concern- 
ing their use.""" 1 Dr. Harrison Sadler and his colleagues discovered from 
a careful study of 18 unrelated donors that the primary motive for their 
donation was not "the satisfaction of drives or the discharge of infantile 
impulses, but the very personal area of self-identity, a self-ideal quite un- 
conscious to them at the time." 107 In spite of their published findings, the 
Sadler group "continued to hear the remark, 'they [unrelated donors] must 
be crazy to do such a thing, no matter what you say — they are per- 
verted'." 108 

This kind of thinking on the part of transplanters has rarely been ex- 
pressed in formal rules or statements. 109 Although no live related renal 
donors have been used for three years in the United States, the policy of 
physicians as publicly stated does not bar such employment and the Inter- 
national Transplantation Society even acknowledges "that the wish to do- 
nate an organ need not be a sign of mental instability." 110 The deviation of 



from unrelated donors were "free kidneys" obtained from persons who had to under- 
go a nephrectomy for reasons unrelated to transplantation. Fellner, Altruivm Re- 
visited: The Genetically Unrelated Living Kidney Donor (consultant's memorandum), 
at 4 (1972) [Appendix E]. 

infl Sadler, Davison, Carroll, & Kountz, The Living Genetically Unrelated Kidney 
Donor, 3 Seminars in Psych. 86 (1971). See also pp. 93-94 supra. 

107 Sadler, Summary Notes on a Clinical Decision-Making Model (consultant's 
memorandum), at 1 (1972) [Appendix HJ. 

10 8 Id. 

,nn The French position, as expressed before the National Academy of Medicine in 
October 1970 by Dr. J. Dormonl, is that "the donor must ... be chosen exclusively 
from among the close relatives of the recipient." Dormont, Les Probltmes Moraux de 
la Transplantation d Organs, 154 BULL. Acad. NAT. M.ED. (Paris) 623 (1970). 

110 Hamburger, et al., A Declaration of the International Society of Transplanta- 
tion, 12 Transplant. 77 (1971). Cf. Bar Council Report on Organ Transplants, 3 
Brit. Mf.d. J. 716 (1971) — approving organ removal from a mentally competent 
donor over 16 years of age who ha9 given his written consent after he had been fully 
advised of the risks. 



313 



202 Stages of Decisionmaking 

practice (or one could say, tacit medical policy) from official policy is, 
at the moment, not too distressing because the success rate of kidney grafts 
from unrelated donors is still below that of any other category (including 
cadavers), since present tissue typing methods apparently do not permit 
the identification of certain important antigenic factors which are absent 
(although undetected) in related donors such as siblings. But, as Dr. 
Fellner notes, 

it is only a question of time before tissue matching with the help of HL-A 
antigen typing, and other typing systems yet to be found, will have progressed 
to the point where, for organ transplantation purposes, the equivalent of a 
monozygotic twin could easily be pinpointed in the population at large. 1 n 

Before such time arises, it will be necessary for policy to be formulated 
on this subject making clear whether genetically unrelated donors should 
be accepted. This is a question which cannot be resolved by physicians 
alone. It concerns such issues as: (1) Does society have any interests in 
preventing a person from making a gift (or, as discussed previously, a sale) 
of an organ if that creates risk to his own life? (2) What level of risk is 
acceptable? (3) What level of "success" of the transplant is necessary, if 
any, to justify the donor's risk? (4) How does the availability of organs 
from other sources, such as cadavers or living related donors, affect the 
decision? (5) What is the relevance of different success rates between living 
unrelated donors and other sources? And (6) what is the relevance of 
surgeons' beliefs with respect to the use of organs from unrelated donors? 

While these questions must be addressed by a public policymaking body, 
such as a special advisory group to the National Institutes of Health or to 
legislatures, it is our opinion that evidence already exists to indicate that 
there are reasons of policy, if not of medicine, to prefer unrelated rather 
than related donors. Unlike Sadler's findings about unrelated donors (who 
were accepted only if they persisted on their own initiative in their offer, 
over a number of months and without encouragement from the transplant 
center), there are many indications that related donors were not true 
volunteers, participating of their own free will. One study showed that 
such donors did not reach their decisions in the thoughtful, rational manner 
which had been assumed by the theorists on consent. 112 Moreover, despite 
physicians' attempts to protect the donor from undue pressures, it is ap- 
parent that veiled or even open pressure from family members as well as 



1,1 Fellner, Altruism Revisited, at 1 (1972) [Appendix E]. 

112 Fellner & Marshall, Kidney Donors: The Myth of Informed Consent, 126 Am. J. 
Psychiatry 1245 (1970); see also Fellner & Marshall. Twelve Kidney Donors, 206 
J. A.M. A. 2703 (1968); notes 27-36 It accompanying text supra. 



314 



Formulation of Policy 203 

unconscious feelings of obligation and other psychological factors weigh 
heavily on family donors. 113 

In most instances, no real decision-making problem existed for the donor. 
Most commonly, he stated that he must give to save the life of the potential 
recipient or he could not face himself. In a sense, he is "called. " It is not 
always a call about which he is enthusiastic, but it is one which he believes 
he is unable to refuse. 114 

From such observations by others and from a review of his own interviews 
with donors (who typically declared "I had to do it"), Dr. Fcllner argues 
that "most donors do not act out of pity or altruism but out of a feeling 
that they have to do this for their own sake." 110 

If this analysis is correct, then physicians appear to have adopted an 
informal policy which excludes people as donors whom the physicians 
believe act from "improper" motives and must be "crazy," when in fact 
those people's donations are a far more "voluntary" expression of their 
own choice and a more "genuine" reflection of a well integrated person than 
arc the donations made by family donors. There is thus a need for others, 
who themselves arc not so emotionally involved as the transplanters clearly 
are, to participate in the formulation of policy in this area. 

Some additional light on decisionmaking with respect to live donors is 
thrown by contrasting medical policy on unrelated donors with that on the 
use of related donors who are incapable of giving valid consent. In most 
circumstances, no thought would be given to using such donors; however, 
where a child in renal failure has an identical twin, physicians favor use of 
the twin as an organ donor since the prognosis is so favorable. 11 * Since 
minors 117 cannot themselves consent to operations, and since it is believed 
that parents or guardians cannot give permission when the procedure is not 



118 See, e.g., Simmons, Hickey, Kjellstrand, & Simmons, Family Tension in the 
Search for a Kidney Donor, 215 J. A.M. A. 909 (1971); Crammond. Renal Homo- 
transplantation: Some Observations on Recipients and Donors, 133 BRrr. J. Psych. 
1223 (1967). 

114 Eisendrath. Gultman & Murray, Psychological Considerations in the Selection 
of Kidney Transplant Donors, 129 Surg. Gynec & Obstet. 243 (1969). 

lir 'Fellner, Altruism Revisited, at 8 (1972) [Appendix E]. He also belieNes that 
these donors experience a feeling of power from their act and gain in self-esteem. 

1.6 Since 1967, one- and two-year survival rate for monozygotic twin transplants 
has been 100 percent. Ninth Registry Report, note 105 supra, at 256. Dialysis is not 
favored as a method of treating children with kidney disease because of the adverse 
effects of the treatment and dietary regime on growth and possibly on the child's 
psyche. 

1.7 Customarily defined as persons under 21, although most states have now made 
18 the age of majority. 



315 



204 Stages of Decisionmaking 

intended to benefit the child, n8 refuge has been taken in court actions. In 
these cases, the judiciary has uniformly approved the physicians' and par- 
ents' request for permission to transplant a kidney from the well to the 
ailing twin. In the first cases, 110 the children were teenagers, who one may 
assume were old enough at least partially to comprehend the contemplated 
operation; thus, their consent and agreement to having their kidneys re- 
moved properly played a role in the courts' reasoning. More recent cases 
have involved much younger children. 120 Here, the weight of the decisions 
has been cast onto the argument that the child-donor does receive a benefit 
by avoiding the psychic harm which would arise from the loss of the twin. 
This seems to be ar^attempt on the part of the judiciary to avoid having to 
confront the policy question of using nonconscnting individuals as donors. 
Some commentators, such as David Daube, have been sharply critical of 
the present practice. 121 There is a pressing need to engage in an open policy 
debate on this subject, which will touch many of the same questions of 
comparative benefits and risks set forth previously in the discussion of un- 
related donors and which will also raise the whole issue of the use of chil- 
dren in medical research. This debate should eventually lead to proposals 
by professional and legislative bodies alike as to the policies which are to 
guide these research activities. 

ii. unpaired organs. The donation of an unpaired organ is tantamount 
to taking one's life. For this reason, we know of no situation in which such 
n donation has been permitted. Paul Blachly has suggested, however, that 
persons engaged in "suicide-prevention" discuss with those intent on sui- 



,,B Although, as was discussed in Chapter Six, the kidney cases in minors are 
usually taken to exemplify the problem of obtaining valid permission for a nonbene- 
ficial intervention, they involve an additional element: namely, that the parents face 
o conflict-of-interest in desiring to help the ailing child through a donation by the 
well child. This conflict may becloud the parents' judgment more than would be 
true in other nonbeneficial (research) interventions. 

1,9 The earliest cases are three unreported Massachusetts decisions growing out of 
operations performed at the Peter Bent Brighnm Hospital. The cases are discussed in 
Curran. A Problem of Consent: Kidney Transplantation in Minors, 34 N.Y.U.L. Rev. 
891 (1959). 

» 20 Hart v. Brown. 289 A. 2d 386 (Conn. Si'per. Ct. 1972)— approval of transplant 
in seven-year-old twin girls. In Strunk v. Strunk, 445 S.W. 2d 145 (Ky. 1969), the 
donor was a 27-year-old inmate of a state mental institution; he was found to have 
a "mental age of approximately six years." 

121 "Children should on no account be donors, and there should be no cheating by 
maintaining . . . that the child would suffer a trauma if he were not allowed to give 
his twin a kidney or whatever it might be." Daube, Transplantation: Acceptability oj 
Procedures and the Required Legal Sanctions, in Ethics in Medical Progress: With 
Special Reference to Transplantation 188. 198 (G.E.W. Wolstenholme & M. 
O'Connor eds. 1966) [hereinafter cited as Medical Progress]. 



316 



Formulation of Policy 205 

cide that they donate a paired organ instead. 122 Blachly argues that since 
potential suicides usually involve depression and feelings of unworthiness, 
the opportunity to help others in a dignified fashion may be very thera- 
peutic. Similarly, the attention given a donor has been viewed as very 
valuable in overcoming the inner forces leading a person to contemplate 
taking his own life. When it comes to the "inevitable case" that still insists 
upon suicide, the question arises whether we should overcome our present 
mores 

to permit such a person to end his own life in a dignified way which would 
permit utilization of his organs. . . . One would think that the stigma that the 
friends and relatives attach to a suicide would be much lessened if they knew 
several persons would live as a result. 123 

The issue of "positive euthanasia" which is raised in an oblique fashion 
by this suggestion was confronted directly a number of years ago by one 
of our consultants, Dr. Belding H. Scribner, in his presidential address to 
the American Society of Artificial Internal Organs: w 

[l]f I knew that I had a fatal disease I would seriously consider volunteer- 
ing to donate one of my kidneys while \ was still well. As far as death is 
concerned, I would like to be able to put into my will a paragraph urging 
that when my physician felt that the end was near, I be put to sleep and any 
useful organs taken prior to death. ... I think that ethical and legal guide- 
lines should be devised to permit me and others to volunteer in these ways. 124 

At the present time a number of groups and individuals are drafting statutes 
on euthanasia and urging their enactment. 125 Although we doubt that such 
measures would meet with widespread approval today, and we have not 
seen any which avoid the conflict-of-interest problem without an impos- 
sibly cumbersome judicial mechanism, we think it is appropriate for persons 
working in the catastrophic disease area to show the effect which euthanasia 
could have on the treatment of disease. 



122 Blachly, Can Organ Transplantation Provide an Altruistic-Expiatory Alterna- 
tive to .Suicide!, 1 Life-Threatening Behavior 6 (1971). 

123 Id. at 9. We would reject this specific proposal because it can easily lead to 
exploitation of the therapeutic relationship. 

124 Scribner, Ethical Problems of Using Artificial Organs to Sustain Human Life, 
10 Trans. Am. Soc. Art. Organs 209, 211 (1964). 

12S The primary concern of the euthanasia proponents is not, of course, organ 
transplants but the pain and expense involved in the prolonged cart of terminal, 
debilitated and often unconscious patients. 



317 

ATTACHMENT E 



Excerpts from 



Catastrophic Diseases: 
Who Decides What? 



A Psychosocial and Legal A nalysis 

of the Problems Posed by Hemodialysis 

and Organ Transplantation 



Jay Katz and Alexander Morgan Capron 



Russell Sage Foundation New York 

1975 



23-029 0-83-21 



318 

Stages of Decisionmaking 



Present organ-sharing arrangements are informal and nonbind.ng. Once 
the kidneys are obtained, how they are distributed is currently a matter 
mostly of who salvaged the kidneys."" Although it is true under the Uni- 
form Anatomical Gift Act that physicians act as "recipients of cadaver 
organs it is clear that the intent of the Act was that they were only trustees 
and that they need be given no personal control ovei who receives the 
organs Therefore, there should be no legal impediments to moving beyond 
the present informal systems, such as that operated out of UCLA. More 
than 500 organs have already been shared among more than 90 transplant 
centers through the UCLA tissue-matching and recipient registry but the 
nonmandatory nature of the system creates problems of its own. Less than 
the best matches occur for two reasons. First, part.c.pat.ng transplant 
centers typically share only one kidney from the cadaver and keep the 
other for one of "their own" patients. Second, a center winch has shared a 
kidney gets a "credit" which places it in a preferential position for receiv- 
ing future kidneys from other centers. 

The emphasis on the "ownership" of the donated kidney thus biases the 
choice of the recipients according to the center at which they are await.ng 
treatment rather than solely according to the medical probabilities (e.g., 
closeness of tissue type, surgical success record of physician Performing 
the operation, etc.). As techniques of organ preservation and tissue match- 
ing are perfected, there is no excuse for a continuation of a system which 
relies on arbitrary, nonmedical factors in the assignment of scarce resources 
such as cadaver organs. 23 If a transplant center wishes to participate in a 
national organ-sharing arrangement, in order to increase the range : of : ussue 
types it can offer to patients, it should be obliged to share all the cadave 
organs which become available to it. We are not persuaded of the danger 
that physicians' motivation to seek cadaver organs will be destroyed rf the 
organs are going to be shared with the best-matched patients at otbe 
hospitals. The greater supply of, and better chances with, such organs wil 
provide sufficient motivation for physicians, who-like potential donors 
and their families-will be made more aware of organ donation as a con- 

22Tcrasaki, Organ Transplantation (consultant's memorandum), at 3 (1972) [Ap- 
pendix K]. The informal system of organ sharing has nevertheless been "markably 
Successful, although a much greater degree of organization »"< «£P e » l,on Trf M 
needed to produce an adequate supply of cadaver kidneys. By 1 972 nearly half of. 11 
cadaver kiLys transplanted were obtained from other hosp.ta Is (600 shared I w.thm 
the same city and 455 shared between cities). A wide, nal.on.l pool o f donos nd 
recipients is particularly necessary.to avoid mismatches caused by ^^^ 
See Opelz 4 Terasaki, National Utilization of Cadaver Kidneys for Transplantation, 

2 V£e M rL™ wltL * McClelland. National Transplant Communicanons 
Network, 218 J.A.M.A. 1674-78 (1971). 



319 



Administration of Major Medical Interventions 237 

tribution to an important national need with the potential of saving many 
lives. 

2. Research v. Therapy 

An example of a national administrative decision of a very different type 
would be the need to decide when an intervention designated as "research," 
in the sense discussed in Chapter Eight, has become "therapeutic." Al- 
though basic policies on this and similar matters will have been established 
previously at the formulation stage, these policies are not self-executing. 
Thus, national bodies must keep abreast of the progress of catastrophic 
disease research and treatment in order to determine, inter alia, when a pro- 
cedure which had been available only on a limited "research" basis should 
be more widely offered or whether a procedure which had called for review 
by the local Institutional Advisory Committees should be regarded as no 
longer needing protocol approval. 



320 

ATTACHMENT F 
Excerpts from 



Summing Up 



Final Report on Studies 
of the Ethical and Legal 
Problems in Medicine 
and Biomedical and 
Behavioral Research 



March 1983 



President's Commission for the Study of 
Ethical Problems in Medicine and 
Biomedical and Behavioral Research 



321 

72 Summing Up: Chapter 4 



* 



if * 



Limited Resources. As has already been noted, the princi- 
ples of serving well-being and promoting self-determination 
sometimes point in conflicting directions. Yet in the normal 
course of treatment and research, pursuing them in tandem 
tends toward the achievement of people's health as they define 
it. The capabilities of the biomedical sciences both to prevent 
and to cure illness have expanded immensely in the past half- 
century; today, health care can offer dramatic remedies for 
previously untreatable conditions. Nonetheless, an important 
factor confounds the pursuit of the goal of good health to the 
full extent indicated by the well-being and self-determination 
principles: the inescapable reality of limited resources. As the 
capabilities of health care have expanded, the strain placed on 
already strapped personal budgets, employer-provided health 
benefit programs, and the treasuries of governments at all 
levels — from local to Federal — has become a matter of increas- 
ing concern. 

The reality of restricted resources means patients, health 
care professionals and institutions, and society at large must 
face an ethical problem: having to choose the uses to which 
limited — in some cases, very scarce — resources will be put. 
The choices require comparing health care expenditures with 
other areas of public and private spending, as well as with 
choices within the health care budget — between treatment and 
research; between restorative steps for those already ill and 
preventive steps for those who may be at risk; among different 
age-groups, diseases, treatment settings, and so forth. 

The ethical dilemmas created by the competition for 
limited resources were vividly displayed in the late 1960s by 
the efforts to save the lives of patients with kidney failure. Two 
treatments were available. First, if a donor could be found, a 
patient's diseased kidneys could be replaced by a healthy 
kidney. Transplantation offered a "cure" when it was success- 
ful, but the supply of kidneys was inadequate and even when 



322 

Recurrent Themes 73 



transplantation occurred in most caBes it did not succeed 
because of organ rejection, infection, or the failure of the new 
kidney for some other reason. Alternatively, patients could 
undergo hemodialysis two or three times a week, during which 
their blood was run through a machine for six to eight hours to 
cleanse it of impurities. While improvements were constantly 
being sought in both forms of treatment, dialysis was regarded 
as a proven and reliable (albeit arduous and expensive) 
method for saving the lives of people who were often otherwise 
healthy and who, if treated, could look forward to an indefinite 
continuation of a nearly "normal" life. 

Since there were many more people with end-stage renal 
disease than the dialysis facilities could accommodate, various 
methods were adopted to select the patients who would be 
treated. The tragedy of the situation received extensive 
coverage in the media, including articles about groups like the 
"God Committee" in Seattle, ordinary citizens who had to 
decide who in their community most deserved this life-saving 
resource. At other hospitals, dialysis was allocated on a first- 
come-first-served basis or according to patients' ability to pay. 9 

By the early 1970s — as the number of people treated 
moved beyond the small percentage it had been during the 
early, experimental stages to a greater (though still fractional) 
portion of the total need — the contrasting fates of those treated 
and the larger number who died untreated — became intolera- 
ble. Rather than continue to seek methods of allocating the 
resource fairly, a decision was made to make it available to 
every American with end-stage renal disease under a special 
provision in the Medicare program. 

This response to the dilemma of limited resources is 
understandable. Indeed, it may have been inevitable, given the 
drama of identifiable patients who died because they could not 
obtain life-saving medical treatment. Moreover, the cost of 
overcoming the tragedy seemed acceptable — in part because of 
the way in which the number of "eligible" patients was 
estimated. Over the past decade, however, expenditures on the 
End Stage Renal Dialysis Program (now totaling approximately 
$2 billion per year) have exceeded the original estimates 
manyfold and the standards for eligibility for dialysis, no 
longer constrained by a scarcity of resources, have expanded 
to include many patients whose age or concurrent diseases 
would have left them out of the calculations of the relevant 
"pool" of patients in 1972." 



• Jay Katz and A. M. Capron, Catastrophic Diseases: Who Decides 
What?. Russell Sage Foundation. New York (1975) at 184-96. 
10 This serves as another reminder of the interaction of "facts" and 
"values" — in this case, the understandable (and probably uncon- 
scious) tendency of physicians to exclude from eligibility for dialysis 
those patients whose characteristics made their prognosis least 



323 

74 Summing Up: Chapter 4 

Dramatic, "big ticket" treatments like kidney dialysis and 
transplantation — or the implantation of an artificial heart at 
the University of Utah Medical Center in late 1982 — are not yet 
the major strains on the health care budget, but they do 
crystallize the ethical issues posed by limitations on society's 
resources. The Commission concluded that these issues cannot 
be avoided by the sort of response — "give everyone all they 
need" — that was used for kidney failure. Instead, the Commis- 
sion turned to the ethical principle of equity. This principle is 
always a hard one to know how to apply — as can be seen in 
the role it played in several Commission reports. 

It received greatest attention in the report on the ethical 
and legal implications of differences in people's access to 
health care. On the one hand, the Commission concluded that 
the importance of health care — in promoting well-being, pre- 
venting death and disability, relieving pain, restoring function- 
ing, and generally ensuring opportunity — and the uneven and 
largely undeserved incidence of illness generated an ethical 
obligation of society in this area that does not necessarily exist 
regarding other things. Yet the principle of equity does not 
create a "right" to health care equal to all the care that some 
people may obtain for themselves, nor even all that people may 
want or need, in the sense of its being of some benefit. Rather, 
equity requires that people have access to an adequate level of 
care and that the costs of care be fairly distributed. As is 
always the case in dealing with general principles, such as 
equity, many of the hardest questions — such as "what level of 
care is adequate?" and "what constitutes fair distribution?" — 
remain to be resolved in the context of particular decisions. 
Instead of searching for a definitive interpretation of the 
concepts, the Commission attempted to set forth terms of 
reference by which those who are responsible for formulating 
policy on health care could compare the ethical implications of 
alternative proposals. 



favorable. Unlike choices between patients based on such social 
factors as wealth, education, marital and parental status, and the like, 
the criteria of "medical suitability" were regarded as "objective." 
With sufficient resources, it proved possible to redefine "suitability" 
since the patients with less favorable prognoses were no longer 
competing with those who "deserved" the treatment more because 
their prognoses were better. Though few would argue with a decision 
to use scarce resources for those most likely to benefit from them, any 
decision based on people's deserts is plainly one that involves values, 
not merely objective facts. 



324 



ATTACHMENT G 
Excerpts from 



Securing 
Access to 
HealthCare 



A Report on the 
Ethical Implications of 
Differences in the 
Availability of 
Health Services 

Volume One: Report 
March 1983 



President's Commission for the Study of 
Ethical Problems in Medicine and 
Biomedical and Behavioral Research 



325 

An Ethical Framework 35 



4- 



jl -a 



Meeting the Societal Obligation 

How Much Care is Enough? Before the concept of an 
adequate level of care can be used as a tool to evaluate 
patterns of access and efforts to improve equity, it must be 
fleshed out. Since there is no objective formula for doing this, 
reasonable people can disagree about whether particular 
patterns and policies meet the demands of adequacy. The 
Commission does not attempt to spell out in detail what 
adequate care should include. Rather it frames the terms in 
which those who discuss or critique health care issues can 
consider ethics as well as economics, medical science, and 
other dimensions. 

Characteristics of adequacy. First, the Commission con- 
siders it clear that health care can only be judged adequate in 
relation to an individual's health condition. To begin with a list 
of techniques or procedures, for example, is not sensible: A CT 
scan for an accident victim with a serious head injury might be 
the best way to make a diagnosis essential for the appropriate 
treatment of that patient; a CT scan for a person with 
headaches might not be considered essential for adequate 
care. To focus only on the technique, therefore, rather than on 
the individual's health and the impact the procedure will have 
on that individual's welfare and opportunity, would lead to 
inappropriate policy. 

Disagreement will arise about whether the care of some 
health conditions falls within the demands of adequacy. Most 
people will agree, however, that some conditions should not be 



326 

36 Securing Access to Health Care: Chapter 1 



included in the,societal obligation to ensure access to adequate 
care. A relatively uncontroversial example would be changing 
the shape of a functioning, normal nose or retarding the normal 
effects of aging (through cosmetic surgery). By the same token, 
there are some conditions, such as pregnancy, for which care 
would be regarded as an important component of adequacy Ln 
determining adequacy, it is important to consider how people s 
welfare, opportunities, and requirements for information and 
interpersonal caring are affected by their health condition. 

Any assessment of adequacy must consider also the types 
amounts, and quality of care necessary to respond to each 
health condition. It is important to emphasize that these 
questions are implicitly comparative: the standard of adequacy 
for a condition must reflect the fact that resources used for it 
will not be available to respond to other condit,ons. Conse- 
quently, the level of care deemed adequate should reflect a 
reasoned judgment not only about the impact of the condition 
on the welfare and opportunity of the individual but also about 
the efficacy and the cost of the care itself in relation to otfier 
conditions and the efficacy and cost of the care that is 
available for them. Since individual cases diff er so much Ihe 
health care professional and patient must be flexible. Thus 
adequacy, even in relation to a particular health condition, 
generally refers to a range of options. 

The relationship of costs and benefits. The level of care 
that is available will be determined by the level of resources 
devoted to producing it. Such allocation should reflect the 
benefits and costs of the care provided. It should be empha- 
sized that these •'benefits." as well as their "costs should be 
interpreted broadly, and not restricted only to effects easily 
quantifiable in monetary terms. Personal benefits include 
improvements in individuals' functioning and in their quality of 
life and the reassurance from worry and the provision of 
information that are a product of health care. Broader social 
benefits should be included as well, such as strengthening the 
sense of community and the belief that no one in serious need 
of health care will be left without it. Similarly, costs are not 
merely the funds spent for a treatment but include other less 
tangible and quantifiable adverse consequences, such as 
diverting funds away from other socially desirable endeavors 
including education, welfare, and other social services. 

There is no objectively correct value that these various 
costs and benefits have or that can be discovered by the tools 
of 'cost/benefit analysis. Still, such an analysis, as a recent 
report of the Office of Technology Assessment noted can be 
very helpful to decisionmakers because the process of analysis 
gives structure to the problem, allows an open consideration of 



327 

An Ethical Framework 37 

all relevant effects of a decision, and forces the explicit 
treatment of key assumptions." 27 But the valuation of the 
various effects of alternative treatments for different condi- 
tions rests on people's values and goals, about which individu- 
als will reasonably disagree. In a democracy, the appropriate 
values to be assigned to the consequences of policies must 
ultimately be determined by people expressing their values 
through social and political processes as well as in the 
marketplace. 

Approximating adequacy. The intention of the Commis- 
sion is to provide a frame of reference for policymakers, not to 
resolve these complex questions. Nevertheless, it is possible to 
raise some of the specific issues that should be considered in 
determining what constitutes adequate care. It is important, for 
example, to gather accurate information about and compare 
the costs and effects, both favorable and unfavorable, of 
various treatment or management options. The options that 
better serve the goals that make health care of special 
importance should be assigned a higher value. As already 
noted, the assessment of costs must take two factors into 
account: the cost of a proposed option in relation to alternative 
forms of care that would achieve the same goal of enhancing 
the welfare and opportunities of the patient, and the cost of 
each proposed option in terms of foregone opportunities to 
apply the same resources to social goals other than that of 
ensuring equitable access. 

Furthermore, a reasonable specification of adequate care 
must reflect an assessment of the relative importance of many 
different characteristics of a given form of care for a particular 
condition. Sometimes the problem is posed as: What amounts 
of care and what quality of care? Such a formulation reduces a 
complex problem to only two dimensions, implying that all 
care can readily be ranked as better or worse. Because two 
alternative forms of care may vary along a number of 
dimensions, there may be no consensus among reasonable and 
informed individuals about which form is of higher overall 
quality. It is worth bearing in mind that adequacy does not 
mean the highest possible level of quality or strictly equal 
quality any more than it requires equal amounts of care; of 
course, adequacy does require that everyone receive care that 
meets standards of sound medical practice. 

Any combination of arrangements for achieving adequacy 
will presumably include some health care delivery settings that 
mainly serve certain groups, such as the poor or those covered 
by public programs. The fact that patients receive care in 
different settings or from different providers does not itself 

v Office of Technology Assessment, U.S. Congress, The Implications 
of Cost-Effectiveness Analysis of Medical Technology, Summary. 
U.S. Government Printing Office. Washington (1980) at 8. 



328 



38 Securing Access to Health Care: Chapter 1 




show that some are receiving inadequate care. The Commis- 
sion believes that there is no moral objection to such a system 
so long as all receive care that is adequate in amount and 
quality and all patients are treated with concern and respect. 

At this point, the complexity of the problem of deciding 
what constitutes adequate care is apparent. However, clear 
and useful conclusions can emerge even when there is no 
agreement on the details of adequacy. In the case of pregnant 
women, for example, there is a consensus in the United States 
that some prenatal care, the attention of a trained health 
professional during labor and delivery, and some continuity 
between the two are all essential for an adequate level of care. 

A stronger consensus is required if proposals for change 
are fo be evaluated. Some of the processes that may be used to 
develop a societal consensus on adequacy are already a 
familiar feature of the health care system, and do in fact play a 



329 

An Ethical Framework 39 

role in determining the amount of care that is provided, 
especially to beneficiaries of public programs. 28 

Professional judgment. Physicians and other professionals 
who provide health care are familiar with human needs for 
care, so that the first means that might be employed in defining 
an adequate level of health care would be a reliance on 
individual health care practitioners' judgment of the "medical 
necessity" of any particular service. However, sole reliance on 
professional judgment in setting limits is not appropriate 
because of professionals' tendency to provide all possible 
medically beneficial care. At the very least, the extent and 
manner in which professionals exercise judgment to limit the 
use of care that is of little benefit (relative to cost] varies 
widely. Thus, without substantial changes in individual health 
care professionals' present practices, this method of defining 
adequate health care is likely to result in an uncertain and 
overly inclusive definition. 

Another way that professional judgment might be used to 
define adequacy is to rely on the standards of medical practice 
as adopted by the professonal community through, for exam- 
ple, consensus conferences. The advantage of such an ap- 
proach is the specialized knowledge of the effects of care that 
such people have. However, there are also serious disadvan- 
tages. 

Professionals have no special expertise in deciding how 
the effects of medical care ought to be valued, either with 
respect to the relative value of different dimensions of care or, 
particularly, the value attached to health care relative to other 
goods. In the last two or three decades, for example, there have 
been major changes in prenatal and obstetrical care, in many 
cases in response to the preferences of parents: changes in the 
use of anesthesia; the kind of contact possible between mother, 
father, and infant in the hospital; the information provided to 
the family about the birth process; support for breast-feeding 
as opposed to formula-feeding. These changes were never 
shown to be harmful or uniformly beneficial, but rather 
represent differences in the valuing of benefits. 29 

Professionals often have no special knowledge of the costs 
of different alternatives and perhaps little appreciation of the 
other goods foregone for the sake of health care. Studies show 

** For a discussion of determinations of the amount and type of care 
under public programs. Bee Chapter Three infra, although the pro- 
cesses now used would not necessarily have the same role in the 
determinations of adequacy recommended here. 

" (n many cases there is now a medical consensus that the new 
practices are in fact superior. Nevertheless, strong pressure from 
consumer* was required to bring some of them about 



330 
40 Securing Access to Health _Care: Chapter 1 



that practitioners are frequently unaware of the financial costs 
of many of the tests and procedures that they order." 

Finally, their involvement with the delivery of care may 
sometimes'create a barrier to full , =on.,dera ion of a 1 o£ ion, 
Manv observers have noted a bias in health care in ims 
cluntrytwaTd the introduction of expensive high-technology- 
based procedures delivered by existing institutions -n^n. 
the introduction of alternative ways to provide services at 
lower cost." 

Because of these factors, professional judgment cannot 
«;tand alone as the determinant of adequate care, but the 

pTc^d knowledge of health care Profesf nal. abou the 
effects of health care is essential as part of any process ot 
determining adequacy. 

^^^^cujrenU^ The United States at present has a 
sophlSSeTl^aTtr^e system and there is reason to 

uppose that the average American obtains an adeq-ate toUd 
amount of care. Defining adequacy in ^^f.^^ of 
nresentlv enjoyed by the average person has the advantage o 
?ea ism it reflects the outcome of the health care system as it 
now operates-what actually happens as a result of patient- 

res dents a„d even medical faculty are equally uninformed about the 
or ces of the tests and treatments they order." Anthony L. Komaroff. 
The Doctor the Hospital and the Definition of Proper Medical 
Practice (1981). Appendix U. in Volume Three of this Report a 
Education Tin sectfon five. Komaroff cites a number of »n.d.e. a. 
Samples S P. Kelly. Physicians' Knowledge of Hospital Costs. I 
F X A Xc 171 (1978); S.J Dresnick et ah, The Physician's Role in the 

Cast^nlinJent Problem. 241 J.A.MA 1606 ^^^tV* 
al Medical Students' Unfamiliarity with the Cost of Diagnostic Tes^ 

50 J Med. Educ 683 (1975); L.R. Kirkland. The Physician and Cast 
Containment, 242 J.A.M.A. 1032 (1979). following 

« Dean David Mechanic of Rutgers University gives the following 

example of this: 

One of the most prevalent conditions among children is sore 
Croats, and it is routine to take a throat culture before 
u^eatment to assess whether the cause is a streptococcal 
Section. Typically, the mother is required to bnng the child to 
a pediatrician forthe culture, often involving inco„ve„.ence 
and considerable expense. As an experiment at the Cohimb a 
Medical Plan has demonstrated, mothers can be effectively 
taSructed to take a throat culture at home, negating the need 
o Vhysician and nurse care in most instances and -creasing 
the convenience and satisfaction of the mother The bam J 
individual responsibility built in to medical care must be 
' reviewed carefully, and efforts should be made to modify them. 

David Mechanic. Future Issues in Heal™ Care: Social Policy ^ and 

the Rationing of Medical Services. The Free Press. New York (1979) 

at 37 (citation omitted). 



331 

An Ethical Framework 41 

provider interaction, not merely what planners believe ought to 
happen. 

Nevertheless, there are good reasons to pause before 
adopting "current use" as the benchmark of adequacy. Many 
distortions in people's true preferences for health care affect 
the average level of care received — for example, those whose 
access is now unduly limited bring down the average, while 
those who overspend for health care because of insurance and 
tax advantages (discussed in Chapter Three) inflate the 
average. Also, structural characteristics of the delivery system 
can mean that even people with good access do not necessarily 
receive an appropriate mix of services. 

A possible variation of the concept of average use is to 
adopt as a point of reference the care received by people of 
average financial means who live in areas that are sufficiently 
provided with health care resources. This approach could 
incorporate a broader dimension of preferences, including an 
explicit consideration of the value of care relative to its cost. 
Unlike most approximations of adequacy this concept is more 
amenable to measurement. In fact, a modification of average 
use — people with similar health conditions receiving the same 
volume of care at a standard acceptable to middle-class 
Americans — is now employed by the Robert Wood Johnson 
Foundation in determining when adequacy is achieved. 52 

Unfortunately, this approach also has its weaknesses. 
Again, in making choices about health care, patients may 
inappropriately evaluate those costs that are covered by 
insurance. Moreover, recognizing their lack of knowledge, 
patients generally rely heavily on their practitioner's judgment, 
which as noted earlier may favor care that is disproportionate- 
ly costly relative to its benefits. On the other hand, if a patient 
makes an independent choice it may be an uninformed one 
that rejects care that is actually of significant benefit relative 
to its cost. Thus, people of average means may lack some care 
that ought to be part of an adequate level while they receive 
some care that ought not to be included in it. 

Nevertheless, this concept also has a role to play in 
determining adequacy. In particular, if some of the distorting 
factors could be lessened, the care sought by well-educated 
people of average means might be a reasonable benchmark, at 
least for the treatment of serious conditions. 

List of services. Another alternative is to attempt to 
specify a list of services to be included within an adequate 
level of health care. An example is the list of "basic health 
services" in the Health Maintenance Organization (HMO) Act 
of 1973 (as amended), which includes physician services, 



12 Testimony of Robert J. Blendon, transcript of 24th meeting of the 
President's Commission (SepL 10, 1982) at 21. 



332 

42 Securi ng Access to Health Care: Chapter 1 

inpatient and outpatient hospital services emergency health 
se™ ces. short-term outpatient mental health services up to 20 
visTtsl reatment and referral for drug and alcohol abuse, 
laboratory work and X-rays, home health services, and certain 
preventive health services." 

The broad categories on this list might be broken down 
into more specific se'rvices. However, such . list of *™ 
no more a specification of an adequate level of care than a hat 
of foods is an adequate diet. What makes the HMO list in to an 
"adequate level" specification is its combination with a 
delivery mechanism P that relies on professional judgment to 
determine the appropriate amounts of services on t . «.e-b£ 
raqp basis with organizational and financial incentives to 
weTgh^ie benefits of services against cost. Other approxima- 
tions in this same spirit include insurance contracts that 
Incorporate reviews of the appropriateness of services re- 
ceived. 

Overall evaluation. It would, of course, be possible to 
combine several "a^pToaches- by specifying categories of 
L'ices that m Ust ^available as part of adequate care, for 
Sample, while placing limits on the overall use of s™ 
through a health insurance package valued at a specified 
amount. Another variation of this approach would involve an 
effort by the medical profession to redefine standards of 
practice to incorporate some assessments of the costs and 
benefits of acceptable alternative therapies. This might be 
achieved through medical education, consensu, wntonce. 
and other methods. Such determinations would of course take 
place within a process that allowed an interplay between the 
heaWi^re professions and political and other social factors. 

The Commission cites these alternatives as examples of 
possible initial approaches to approximating an adequate level 
of health care that should be available to all Americans. There 
are both theoretical and practical differences between these 
approaches, yet each has something to offer, separately and 
Together. For the purpose of health policy formulation, general 
Stories as well as ordinary views of equity do not determine a 
unique solution to defining adequate care but rather set some 
o?oad limits within which that definition should fall. is 
reasonable for a society to turn to fair democratic political 
procedures to make a choice among just alt eniatives. Gn enfce 
£reat imprecision in the notion of adequate health care 
however, it is especially important that the procedures used to 
define that level be— and be perceived to be— fair. 



l^aHhMaintenance Organization Act ofT973 [Pub. L. No. 93-222). 



333 

Mr. Gore. Professor Capron, that is entirely appropriate. 

We appreciate the approach you take to these issues. You have 
helped us on a number of occasions to understand these matters a 
lot better. 

How do you react from a bioethical perspective to the fact that 
Mr. and Mrs. Fiske were unable to get their child, Jamie, listed as 
a potential liver recipient until they could assure that the insur- 
ance company would pay for the transplant? She was going to die 
if she didn't get it. They couldn't even get her on the list. 

The hospital didn't present it that starkly. I thought his testimo- 
ny was quite good on that point. They won't present it quite that 
starkly, but in fact that is what happens. That is exactly what hap- 
pens. 

Captain Broderick yesterday came here with his daughter, who is 
going to die unless she gets a transplant, and the CHAMPUS pro- 
gram, the Government health care program that takes care of 
active duty military people and their families, refuses to pay. 

Is it unethical for us as a society to say to the parents of these 
children and to the children themselves, that they have to die be- 
cause we think the operation is too expensive? 

Mr. Capron. I think the question is not simply whether it is too 
expensive. As a human being, I react with compassion and with 
concern for those people. If I were a physician and being asked to 
perform a treatment for free, or a hospital administrator and being 
asked to absorb those costs and pass them on to other people, in 
effect, that would be a difficult question for me to answer. I believe 
I would like to say that I would try to help that particular person. 

But what we are talking about here in the Commission's view is 
a standard for making some form of public policy which has to be 
based on something other than an individualized, compassionate re- 
action to an individual situation. We need a number of mecha- 
nisms through which to judge whether liver transplantation is part 
of that adequate level of care that society is obligated to insure is 
provided to everyone? 

To do that, there are a number of mechanisms. One is the mech- 
anism which I believe the CHAMPUS program has cited, which is 
to say is this a procedure which is regarded by physicians as now of 
proven benefit. Even if someone says I have a technique that might 
save someone's life, we wouldn't necessarily run to pay for that as 
part of established medical care until it has some proven benefit. 

That is not the end of the discussion, in the Commission's view. 
That is only one way in which adequacy can be determined. An- 
other is to look at what people would regard as the sort of care 
they would expect to receive if they were paying for insurance 
themselves. One of the things about our present insurance system, 
of course, is that it tends to subsidize the purchase of health insur- 
ance so that people have health insurance plans that are much 
more generous than they would have if they were really comparing 
health care with other things. 

After all, we aren't just talking about medical care to save life. 
We are talking about the expenditure of our resources on all the 
aspects of life. So, that is another means of measuring. Already, 
with some of the changes that have been made in the tax law in 
the last Congress, we are moving in that direction, of recognizing 



334 

that subsidized health care through employer, subsidies and so 
forth may tend to be written at a higher level and lead to extrava- 
gance. 

Another thing is to compare this particular condition that you 
are talking about treating, its effect on opportunity and on life, 
with other conditions and ask how we respond there as a society. 
With the precedent established by end-stage renal disease in 
1973, the situation really changed. We now have at least one prece- 
dent which says that when we have a disease that can be treated 
in this way, with roughly this sort of expenditure of funds, we be- 
lieve in making the social resources available. In effect, as a society 
we are defining that as part of an adequate level. I think that is a 
decision we have to examine and ask how far we press that. 

As I said, we already find physicians having to make choices. 
The example the Commission gave is that it would not seem justi- 
fied, although the funding is literally there, to use the resources to 
treat a patient who goes into kidney failure who is in a permanent 
state of unconsciousness, because the benefit to the patient would 
be so small. 

So, I believe one has to compare, in talking about whether soci- 
ety has an obligation, the relative benefit of this procedure versus 
other procedures. It is a matter of beginning with those things 
about which we have greatest agreement and working outward 
from there. Liver transplantation now is somewhere on the fringe, 
not close to the core agreement that we have, but something that 
we build out from our core agreement. 

Mr. Gore. Professor Capron, I get the feeling that maybe there is 
some sensitivity on the part of the Commission after the reaction 
to your report on the obligation of society to provide care. At least 
I hear a great deal of caution in your response. 

Mr. Capron. I don't mean to be cautious so much as saying that 
this is not a subject to which I think a simple answer can be given. 
Mr. Gore. Let me change the question slightly. If one accepts as 
fact the testimony of the leading experts in the world, who testified 
here yesterday, that there is now a 75 percent success rate with 
this procedure, and if you further accept as the fact the assertion 
that in many, if not most, of these cases the cost of providing for 
care up to and until death will exceed the cost of the transplant 
intervention, which saves that person's life, then is it unethical for 
us to tell the families of these children that they can't have the 
operation because society can't afford the up-front cost of the trans- 
plant. 

Mr. Capron. I don't think that this is a forum in which that deci- 
sion can be made. I can give you my response to it, which is if you 
are saying that you are already agreeing and obligated to pay so 
many hundreds of thousands of dollars for care which is merely, in 
effect, custodial care for a person as they die and isn't providing 
them any cure, it would seem, just from the viewpoint of saving 
the money, that it is not a matter of ethics, it is a matter of 
common sense to say one would prefer to spend the money to give 
the person a 75-percent chance of then living a normal life. 

The problems with reaching a generalization from that is that 
that is not the case with a lot of the sorts of conditions we are talk- 
ing about. That, in a way, is a convenient peg to hang that particu- 



335^ 

lar example on. Unfortunately, a lot of the examples are not going 
to fit that way. 

A person who is in end-stage renal disease may die quite rapidly. 
If we didn't have the present program, I think it would be very 
hard to make that argument. At the time that Dr. Barney Clark 
died, at his funeral, Wilhelm Kolff, who was the inventor of the ar- 
tificial kidney and a primary inventor of the present mechanically 
implanted "Jarvik heart" that was used for Dr. Clark stated, in his 
view, "We are now ready to give relief to the tens of thousands of 
victims of heart failure in this country." There will be people who 
believe that now and who will say since Barney Clark lived for 5 or 
6 months, that is a success. Are we prepared now to make that de- 
termination for the artificial heart? 

I think we have to look at all the facts of a case. In many of 
those cases we will not have the more convenient out of saying 
look, it is just good, prudent economics to spend the money to try 
to give a cure rather than to spend the money to just watch some- 
one die. 

Mr. Gore. We will pursue that with our other witnesses, but it 
seems to me a related issue is how quickly the system responds 
with updated bioethical judgments to new and different facts, such 
as a dramatically improved success rate and the new figures on the 
economics of the procedures involved. 

Mr. Capron. One ability that the system had prior to 1981 to re- 
spond was the National Center for Health Care Technology, which 
was established in 1978 and had 3 years of life. It was beginning to 
give exactly that kind of more sophisticated advice to the Health 
Care Financing Administration and then was eliminated. There 
are means by which people can give advice of the sort that you are 
saying so that the system does respond. 

Mr. Gore. Let me try one more time. Let me ask the question a 
little different way. Let's try it one more time and then we will let 
you go and go to the other witnesses. 

Leaving the fact that you can probably save money out of it, here 
you have got a child. This child is going to die within two months. 
Her parents don't have the money to pay for the operation. If she 
gets the operation, she will almost certainly live a normal, healthy, 
productive life. 

We as a country look at that set of circumstances. If we say to 
the parents of that child, your child must die because we don't feel 
any obligation to help you finance the operation that will save her 
life. 

In your opinion, if society made that decision, would it be justi- 
fied in doing so? Let me ask the question a little bit differently. 
You are telling me, in your responses, that the answer is now 
clear. You don't think the answer is clearly yes, we have an obliga- 
tion to save that child's life in those circumstances? 

Mr. Capron. That is correct. The situation I think is different 
from the personal obligation because when we make societal judg- 
ments like this we establish a statement about our obligations not 
just toward that one child, but toward many people in the situa- 
tion. Is the fact that it is a child important in your example, for 
example? What about a 50-year-old person. What is the difference? 
It is a human life. 



336 

Mr. Gore. I am not sure I can define a legalistic distinction. It 
makes it easier for me to understand it. Maybe that is wrong on 
my part. 

Mr. Capron. Whenever you have an example, you have a child 
who has fallen into a well or a miner trapped in a mine, we will 
spend tens or hundreds of thousands of dollars to try to get the per- 
sons out of the predicament on the possibility that they are alive. 
People will risk their lives to get that identifiable person. 

Of course, when you have a Jamie Fiske or any other identifiable 
child and the basic statement is that what stands between that 
child and a chance at life is money, we want to say spend the 
money. It is small potatoes to the things that are on the walls of 
this conference room. We spend all that money shooting things up 
into space, and we are talking about saving a human life. 

If it were my decision, sir, my answer would be save that life. 
But I recognize that we are not just talking about that one child. 
We are talking about a statistical problem. The fact of the matter 
is, although we have that compassion, we haven't done a lot yet to 
make the organs available that are necessary. Why should we be 
talking about money? Here is something which we can give with- 
out cost. I don't know how many people in this room have organ 
cards. How many people have taken that step? 

If we're talking solely about the money, it may well be that the 
liver transplant situation is the kind of situation where we ought 
to include that now. We ought to say CHAMPUS, medicare, medic- 
aid and Blue Cross, to the extent that we influence the private pro- 
grams and so on, yes, they ought to pay. It has established value 
and it is life-saving and so forth. 

I am just saying it is not simply a question of money. We still 
end up with hard choices as to the indications in any particular 
case. Moreover, there are other things that society could do. I 
would like to see us not forget about those as well. 

Mr. Gore. Thank you very much, Professor Capron. I have too 
much respect for your judgment not to pause at the fact that I dis- 
agree with you slightly on this. 

Mr. Capron. Why don't you come to my class and we will talk 
about it there? Then I am sure you will agree with me. 

Mr. Gore. Thanks anyway. 

Dr. Veatch and Dr. Childress, thank you for your indulgence. We 
will continue the panel with you, Dr. Veatch, the professor of medi- 
cal ethics and senior research scholar at the Kennedy Institute of 
Ethics at Georgetown University. 

Thank you for your patience and for your willingness to contrib- 
ute to this hearing. 

Mr. Veatch. Thank you very much. 

I have been asked to review bioethical and religious issues sur- 
rounding organ procurement. I am a Methodist, but I want to 
make clear that I am speaking for no religious or academic group 
and shall try to present as fairly as possible my understanding of 
the views of the major groups on the issues at hand. 

Furthermore, in the interest of time, I want to limit my remarks 
to procurement of cadaver organs and I want to summarize at least 
some of the points that are developed more fully in written testi- 
mony. 



337 

As I understand the contemporary bioethical debate over organ 
procurement, it contains two issues that I will label as preliminary 
and two that are more central. The ethics of the definition of death 
and the ethics of removal of cadaver organs I take to be prelimi- 
nary, while the donation versus salvaging controversy and the 
ethics of fairness in organ distribution I take to be central. 

All of the major religious groups reveal some differences of opin- 
ion over the shift to the use of brain-oriented criteria for the defini- 
tion of death. I summarize those in my written testimony. I will 
skip over them. 

Jumping to my summary, at least some responsible members of 
all of the major religious traditions accept the brain-oriented defi- 
nition theologically and find it appropriate as a basis for procuring 
cadaver organs, at least for lifesaving interventions. 

There is also substantial ethical agreement on what I described 
as the second preliminary ethical question, the ethics of the remov- 
al of cadaver organs. There has been in general no objection among 
either the religious or the secular bioethical community to the re- 
moval of organs for lifesaving purposes, although there are objec- 
tions of removing them for other purposes, once it has been estab- 
lished that the patient is indeed dead. 

I would like to focus my attention on what I described as the two 
more critical or central ethical issues. 

First, the controversy over donation versus salvaging of organs. 
It has been recognized for several years that there are really two 
basic alternatives for organ procurement: donation and salvaging. 

It is the second alternative that is favored by virtually every 
writer within the Judeo-Christian tradition and by every religious 
group speaking on the subject. The reason is that according to the 
Judeo-Christian tradition, our respect for the individual and the 
rights associated with the individual do not cease with death. 

In the Judeo-Christian tradition, as opposed, for example, to 
much Greek thought, the body is affirmed to be a central part of 
the total spiritual being. Any scheme that abandons the mode of 
donation in favor of viewing the cadaver as a social resource to be 
mined for worthwhile social purposes will directly violate the cen- 
tral tenets of Christian thought and create serious problems for 
Jewish thought as well, at least when Jews are not in a State gov- 
erned by Jewish law. 

At the same time, there is uniform support in all the major reli- 
gious traditions, not only for the ethical acceptability of donations, 
but the actual moral obligation to take organ donation seriously. 

This suggests that while all traditions would oppose routine sal- 
vaging, the kind of scheme Alex Capron was talking about of just 
taking the organs, these traditions would look favorably upon 
public policies to make donation as easy as possible. 

The public policy implication is that the correct solution to the 
donation versus salvaging controversy is maximum encouragement 
to facilitate donation, provided that this does not subtly coerce 
those unwilling to donate or trick them into donating without real- 
izing it. 

The schemes to indicate willingness to donate on State driver's 
licenses, for example, seem very reasonable. In addition, I would 



338 

endorse all of the schemes that were proposed earlier, Dr. Ogden's 
scheme, making this part of routine admission to a hospital. 

I would also suggest that we look at the possibility of incorporat- 
ing organ donation into Federal documents, especially those al- 
ready computerized for easy retrieval, such as income tax or social 
security records. This provides, in addition, an opportunity for reg- 
ular updating of the individual's wishes. 

The ideal form of the question about willingness to donate would 
permit three responses, yes, no, and no response, thus not creating 
any presumptions or pressures. This strategy seems far preferable 
to continental European public policies authorizing routine salvag- 
ing unless objection has been registered. 

It is even preferable to a British scheme, endorsed by the British 
Working Party of the Health Department in Britain, which would 
give a designated government or hospital official the power to 
remove organs for transplant in cases where no objection has been 
registered and relatives cannot be located. 

This group would die alone without relatives available and is suf- 
ficient small and sufficiently vulnerable that those formulating 
public policy should bend over backward to avoid abusing their 
right to be treated with maximum respect. 

This brings me to the fourth and final, perhaps the most critical 
question of all, that of fairness in distribution of organs once they 
are procured. 

Congressman Gore, in your communication to me about these 
hearings, you indicated that the subcommittee was particularly in- 
terested in looking at approaches to promote efficient distributions 
of organs for transplant recipients. While those standing within the 
religious traditions I am attempting to summarize would be con- 
cerned about efficient distribution, I think they would place at 
least equal emphasis on fair distribution. 

For example, a Detroit newspaper some years ago carried an ad 
with an offer to buy kidneys for $3,000 suitable for transplantation. 
Markets in organs might just turn out to be efficient, but I am con- 
vinced that they would be opposed vigorously by the mainstream of 
the religious traditions I am summarizing. 

They would be opposed, among other reasons, because the alloca- 
tion, though perhaps efficient in maximizing the number of organs 
transplated, would be grossly discriminatory against those unable 
to pay. 

The Judeo-Christian tradition is deeply committed to distribution 
on the basis of need. A single dominant theme of both Jewish and 
Christian ethics has been the responsibility to those in need: The 
lame, the halt, the blind, and now those in need of organs. 

Any allocation scheme that permits other variables, such as abil- 
ity to pay or some judgment about how socially useful a recipient 
will be, has been uniformly opposed by all of the commentators 
working within these traditions. 

Some unfair allocation schemes, it turns out, may not be as bla- 
tant as direct market mechanisms to buy organs. Current medicare 
policy, for instance, prohibits funding of heart transplants under 
Government health insurance and has a similar impact of discrimi- 
nating against the needy. 



339 

It is my sense that spokespeople for religious traditions and the 
theologians writing within these traditions are realists. They recog- 
nize the Government could not make a commitment to pay for all 
possible medical care. That is precisely the point Alex Capron was 
making. They do, however, share with the President's Commission 
the conviction there should be some floor level of health care under 
which no one ought to fall. 

In the allocation of scarce organs for transplant, at least in such 
cases as hearts, kidneys, and livers, where the organs are literally 
lifesaving, allocation is simply unfair if it is based on ability to pay. 

If anyone has access, all should have an equal chance, either by 
some lottery system, random assignment of organs to those in 
equal need, or by some randomness of having to wait in line for 
needed organs. 

That is the conclusion reached by virtually every theologian 
working in the tradition I am summarizing. No one should get an 
organ for transplant or an artificial organ for implant until there 
is a fair, nondiscriminatory allocation system in place which gives 
everyone any equal need for lifesaving organs an equal opportunity 
for access. 

Recently, we have discovered even more subtle problems of fair 
and efficient allocation. What I have to say here is perhaps a bit 
sensitive, and I want to state my views very carefully. 

Some individuals with particular skills in reaching the medical 
profession or the mass media or have been able to procure organs 
for themselves or for their family members. Candice Thomas was 
here earlier this morning. Those supporting her care, according to 
a fundraising campaign on a local radio station, have gotten Presi- 
dent Reagan to volunteer an airplane, presumably Air Force One, 
to transport any donated liver. 

No one can possibly criticize these parents for doing everything 
possible to meet the needs of their loved ones. In fact, they have 
probably increased the efficiency in organ procurement by reaching 
organs that would otherwise go to waste and by increasing public 
awareness. 

As a society, however, I believe we should be ashamed that these 
people are forced to use ad hoc techniques, personal charisma and 
persuasion to obtain organs for their families. It is simply too disor- 
ganized, too ideosyncratic a method. It is unfair to the families in 
crisis. It is unfair to those who lack the power or the access to 
those means of getting organs. 

Either the use of government airplanes to meet these needs is 
justified, and it should be done for all in need of organs, or it is 
not, and it should not be done for any. A much more systematic, 
institutional response is called for, one that in a disciplined way 
makes available every organ within reach donated by a patient or 
the responsible next of kin in a manner that gives all people of 
equal need equal opportunity of access. I think that the Federal 
Government is the only institution that can provide that kind of 
systematic, fair access. 

Some such organized system of fair access is called for by Jewish 
and Christian traditions that I have been asked to summarize. In 
principle, it seems to me that it is the public policy that has to be 
recommended to this committee. 



340 



Thank you. 

Mr. Gore. Thank you very much. That is very thoughtful and 
helpful testimony. We will hold questions until Dr. Childress has 
rounded out the panel. 

[The prepared statement of Dr. Veatch follows:] 



341 

Statement of Robert M. Veatch 

My name is Robert Veatch. I am the Professor of Medical Ethics at 
Georgetown University's Kennedy Institute of Ethics, a research center 
devoted to studying the social and ethical aspects of medicine and health 
policy. I have graduate level training in neuro-pharmacology , a divinity 
school degree from Harvard, and a doctorate in the study of religion and 
society at Harvard where I concentrated in medical ethics. I have been 
asked to review the bioethical and religious issues surrounding organ 
procurement. Although I am a Methodist, I speak for no religious or 
academic group and shall try to present fairly my understanding of the 
views of major religious groups on the issues at hand. 

The bioethical debate over organ procurement goes back at least to 
the first kidney transplants in 1954. The current generation of 
controversy, however, can be dated from December 3, 1967, when Christiaan 
Barnard transplanted the first human heart into the chest of Louis 
Washkansky. In what follows I limit my remarks to the procurement of 
cadaver organs. While organ procurement from living donors, especially 
related donors, appears to be acceptable in cases where the transplant 
would be life-saving for a recipient and would not be life-threatening 
for the donor, there is widespread disapproval of procuring organs from 
living donors when the removal of the organ would be life-threatening. 



342 



Investigations and Oversight Subcommittee 
Robert M. Veatch 
April 14, 1983 

-2- 



In any case, I assume that cadaver organ procurement constitutes the 
critical ethical and public policy problem. It is here that the most 
good can be done by clarifying our ethical and religious requirements. 

As I understand the contemporary bioethical debate over organ 
procurement, it contains two issues I shall label as preliminary and two 
issues that are central or core. The ethics of the definition of death 
and the removal of cadaver organs I take to be preliminary while the 
donation vs. salvaging controversy and the ethics of fairness in organ 
distribution I take to be central. 

All major religious groups reveal some differences of opinion over a 
shift to the use of a brain-oriented definition of death, a shift 
important if organ procurement is to be facilitated. Within Judaism 
there has been the greatest resistance to shifting to a brain-oriented 
defintion of death. Rabbi David Bleich, philosopher at Yeshiva 
University, for example, opposes any shift, saying that "the patient 
cannot be pronounced dead other than upon the irreversible cessation of 
both cardiac and respiratory activity." On the other hand, other 

Rabbis from Conservative and Reformed traditions have endorsed the use of 

2 

brain criteria for death pronouncement. 

Among Catholics Pope Pius XII opened the door for a shift in the 
definition of death in 1957 saying, "it remains for the doctor, and 
especially the anesthesiologist, to give a clear and precise definition 

of 'death' and the 'moment of death' of a patient who passes away in a 

3 
state of unconsciousness." There have never been any principled 

theological objections to a brain-oriented definition of death among 

Catholics although occasionally more conservative Catholics, often those 

associated with right-to-life positions, have expressed fear that 



343 



Investigations and Oversight Subcommittee 
Robert M. Veatch 
April 14, 1983 

-3- 



aclcnowl edging that a person is dead when the brain is dead might 
indirectly lessen respect for those who are still living. 

Protestant theologians (and Protestant groups when they have spoken 
on the subject) have almost uniformly favored some brain-oriented 
definition of death whether they represent more conservative (Paul 
Ramsey) or liberal (Joseph Fletcher) perspectives. Thus while there 
is some concern about the use of a brain-oriented definition of death, at 
least some responsible members of all major religious traditions accept 
it theologically and find it appropriate as a basis for procuring cadaver 
organs . 

More significantly, there is substantial ethical agreement on the 
second preliminary ethical question, the ethics of removal of cadaver 
organs. There has in general been no objection among either the secular 
or religious bioethical community to the removal of organs for 
life-saving purposes from human bodies once it is established those 
persons are dead. Protestants and Catholics have raised no serious 
questions about cadaver organ removal provided appropriate respect is 
shown for the deceased and appropriate permissions are obtained. 

Jewish thought poses a more serious question since in Judaism there 

o 

are religious obligations to bury the dead with organs intact. This 
obligation is superseded when a cadaver organ can be removed for the 
purpose of saving a life of another identified person in need. Thus all 
major religious traditions accept the legitimacy of removing cadaver 
organs for life-saving transplantation. Some may insist on more 
conservative heart-and-lung-oriented criteria for death and some, 
especially Orthodox Jews, may object to organ removal for research or 
educational purposes, but the two preliminary ethical problems pose no 



344 



Investigations and Oversight Subcommittee 
Robert M. Veatch 
April 1A, 1983 



insurmountable obstacles for cadaver organ procurement. In fact, they 
all place a high value on the saving of human life so that while the 
state may not be authorized to salvage organs routinely, individuals bear 
at least a moral obligation to facilitate organ procurement for 
life-saving purposes. 

This brings us to the two more critical and controversial core 
ethical issues. First, the controversy over donation vs. salvaging of 
organs. It has been recognized for years that there are two basic 
alternatives for organ procurement: donation and salvaging. Under 
salvaging schemes, such as that proposed by Dukeminier and Sanders, 
cadaver organs would be routinely made available as needed as a social 
resource. 9 Normally, advocates of salvaging would permit individuals 
to object in writing while living or even permit relatives to object in 
cases where the individual has not expressed his or her wishes. The 
other alternative emphasizes donation. 

It is this second alternative that has been favored by virtually 
every writer within the Judeo-Christian tradition and by every religious 
group speaking on the subject. The reason is fundamentally that 
according to the Judeo-Christian tradition, our respect for the 
individual and the rights associated with that individual do not cease at 
death. Obligations of respect — for the wishes of the deceased and the 
integrity of his earthly remains--must continue. In the Judeo-Christian 
tradition, as opposed to much pagan Greek, thought, the body is affirmed 
to be a central part of the total spiritual being. Any scheme that 
abandons the mode of donation in favor of viewing the cadaver as a social 
resource to be mined for worthwhile social purposes will directly violate 
central tenets of Christian thought and create serious problems for Jews 



345 



Investigations and Oversight Subcommittee 
Robert M . Veatch 
April 14, 1983 - 

-5- 



as well, especially in a state not based on Jewish law. It will, more 
pragmatically, predictably produce vociferous, agitated opposition. 
While I cannot predict street riots comparable to those sparked in Israel 
after the passing of autopsy laws permitting routine violation of the 
corpse, it is safe to say there would be sustained and vocal 
opposition. 

At the same time there is uniform support in all major traditions not 
only for the ethical acceptability of donation, but the actual moral 
obligation to take organ donation seriously. This suggests while, for 
practical and theoretical reasons, all traditions would oppose routine 
salvaging, they would look favorably upon public policies to make 
donation as easy as possible. Given the fact that these religious 
traditions all support organ donation in at least some circumstances and 
in fact consider it a morally weighty obligation, they would favor public 
policies making it as easy as possible to express a willingness to donate 
organs for life-saving purposes. 

The public policy implication is that the correct solution to the 
donation vs. salvaging controversy is maximum encouragement to facilitate 
donation, provided this does not subtly coerce those unwilling to donate 
or does not trick them into donating unintentionally. The schemes to 
indicate willingness to donate on state drivers* licenses, for example, 
would seem very reasonable. In addition, questions on federal documents, 
especially those already computerized for easy retrieval such as income 
tax or social security records, would seem appropriate. The ideal form 
of the question about willingness to donate would permit three 
responses--yes, no, and no response — thus not creating any presumptions 
or pressures on any respondents. This strategy seems far preferable to 



346 



Investigations and Oversight Subcommittee 
Robert M. Veatch 
April 14, 1983 

-6- 



continental European public policies authorizing routine salvaging unless 

12 
objection has been registered. It is even preferable to the scheme 

endorsed by the British Working Party of the Health Departments of Great 

Britain and Northern Ireland, which would give a designated government or 

hospital official the power to remove organs for transplantation in cases 

where no objection has been registered and relatives cannot be 

located. 1 This group who die alone, without relatives available, is 

sufficiently small and sufficiently vulnerable that those formulating 

public policies should bend over backwards to avoid abusing their right 

to be treated with maximum respect. 

This brings us to the final critical question: fairness in the 

distribution of organs once they are procured. Congressman Gore, in his 

communication to me about these hearings, indicated that the subcommittee 

was particularly interested in looking at approaches to promote efficient 

distribution of organs to transplant recipients. While those standing 

within the religious traditions I am attempting to summarize would be 

concerned about efficient distribution, I think it is clear that they 

would place at least equal emphasis on the problems of fair distribution. 

For example, there have from time to time been casual references to 

the use of market mechanisms to promote efficient transfer of organs to 

recipients. A Detroit newspaper some years ago carried an ad with an 

14 
offer to buy a kidney for $3,000. Markets in organs might turn out 

to be efficient, but I am convinced they would be opposed vigorously by 

the mainstream of these religious traditions. They would be opposed 

because the allocation, though perhaps efficient in maximizing the number 

of organs transplanted, would be grossly discriminatory against those 

unable to pay. The Judeo-Christian tradition is deeply committed to 



347 



Investigations and Oversight Subcommittee 
Robert M. Veatch 
April 14, 1983 

-7- 



distribution on the basis of need. The single dominant theme of both 
Jewish and Christian ethics has been the responsibility to those in 
need--the lame, the halt, the blind, and those in need of organs. Any 
allocation scheme that permits other variables such as ability to pay or 
some judgment about how socially useful a recipient will be has been 

uniformly opposed by all commentators working from within these 

.... 15 

traditions. 

Some unfair allocation schemes may not be as blatant as direct market 
mechanisms to buy organs. Current Medicare policy prohibiting funding of 
heart transplants under government health insurance has a similar impact 
of discriminating against the needy. It is my sense that 
spokespeople for religious groups and theologians writing within these 
traditions are realists. They recognize that the government cannot make 
a commitment to pay for all possible medical care. They do, however, 
share with the President's Commission for the Study of Ethical Problems 
in Medicine and Biomedical and Behavioral Research the conviction that 
there should be some floor level of health care under which no one ought 
to fall. In the allocation of scarce organs for transplant, at least 
in cases such as hearts, kidneys, or livers, where the organs are 
literally life-saving, allocation is simply unfair if it is based on 
ability to pay. If anyone has access, all should have an equal chance, 
by some lottery system, random assignment of organs to those in equal 
need, or by the randomness of having each wait in line for needed 
organs. That is the conclusion reached by virtually very theologian 
writing out of the Judeo-Christian tradition and, I am convinced, the 
only one they can reach and be consistent with that tradition's 
commitment to equal treatment based on need. No one should get an organ 



348 



Investigations and Oversight SuDcommittee 
Robert M. Veatch 
April 14, 1983 

-8- 



for transplant (or an artificial organ for implant) until there is a 
fair, non-discriminatory allocation system in place which gives everyone 
in equal need for life-saving organs an equal opportunity of access. 

Recently we have discovered even more subtle problems of fair and 
efficient allocation. Some individuals with particular skills in 
reaching the medical profession or the mass media have been able to 
procure organs for themselves or their family members. Those supporting 
a small child in need of a liver transplant have even, according to a 
fund-raising campaign for a local radio station, gotten President Reagan 
to volunteer Air Force One to transport any donated liver. No one can 
possibly criticize them for fulfilling their obligations to themselves 
and their loved ones to do everything reasonable to serve their needs. 
In fact, they probably increase efficiency in organ procurement by 
reaching organs that may otherwise go to waste and by increasing public 
awareness of the need for organs. As a society, however, the use of such 
ad hoc techniques of personal charisma and persuasion to obtain organs 
should be viewed with skepticism. It is simply too disorganized, too 
idiosyncratic a method. It is unfair to those who lack the power or 
access to these means of obtaining organs. Either the use of government 
airplanes for organ transportation is justified and it should be done for 
all organs, or it is not and and it should not be done at all. A much 
more systematic, institutional response is called for, one that in a 
disciplined way makes available every organ within reach donated by the 
patient or the responsible next of kin in a manner that gives all people 
of equal need an equal opportunity of access. I think the federal 
government is the only institution that can provide that kind of 
systematic, fair access. Some such organized system of fair access is 

called for by the Jewish and Christian traditions that I have been asked 
to summarize. It is the principle of a public policy that I would 
recommend to this committee. 



349 



REFERENCES 

1. J. David Bleich, "Neurological Death and Time of Death Statutes," 
Jewish Bioethics, ed . Fred Rosner and J. David Bleich (New York: Sanhedrin 
Press, 1979), p. 310. 

2. Fred Rosner, "Organ Transplants: The Jewish Viewpoint," Journal of 
Thanatology 3 (1975): 233-41. 

3. Pius XII. "The Prolongation of Life." An Address to an International 
Congress of Anesthesiologists on November 24, 1957. The Pope Speaks 4 (Spring 
1958): 396. 

4. Paul A. Byrne, Sean O'Reilly, Paul M. Quay, "Brain Death—An Opposing 
Viewpoint," Journal of the American Medical Association 242 (November 2, 1979): 
1985-90. 

5. Paul Ramsey, "On Updating Procedures for Stating that a Man Has Died," 
The Patient as Person (New Haven, Connecticut: Yale University Press, 1970), 
pp. 59-112. 

6. Joseph Fletcher, "Cerebration," Humanhood: Essays in Biomedical Ethics 
(Buffalo, N.Y.: Prometheus Books, 1979), pp. 159-65. 

7. Paul Ramsey, "Giving or Taking Cadaver Organs for Transplant," The Patient 
as Person , esp. pp. 205-09; Ethical and Religious Directives for Catholic Health 
Facilities. Directive 30 (Washington, D.C.: Dept. of Health Affairs, United 
States Catholic Conference, 1971), p. 8; Benedict M. Ashley and Kevin D. O'Rourke, 
Health Care Ethics: A Theological Analysis . 2nd edition (St. Louis, Mo.: The 
Catholic Health Association of the United States, 1982), pp. 308-12. 

8. Paul Freund, "Organ Transplants: Ethical and Legal Problems," Proceedings 
of the American Philosophical Society 15 (August 1971) :276; Fred Rosner, "Organ 
Transplantation in Jewish Law," Jewish Bioethics . esp. p. 360. 



23-029 0-83-23 



350 



9. Jesse Dukeminier and David Sanders, "Organ Transplantation: A Proposal 
for Routine Salvaging of Cadaver Organs," New England Journal of Medicine 279 
(1968) : 413-19. 

10. Robert M. Veatch, "A Policy for Obtaining Newly Dead Bodies and Body Organs," 
Death, Dying, and the Biological Revolution (New Haven, Cr .. : Yale University 
Press, 1979), pp. 266-76. 

11. Fred Rosner, "Autopsy in Jewish Law and the Israeli Autopsy Controversy," 
Jewish Bioethics , p. 343. 

12. "France Widens Authority for Transplants from Dead," New York Times , 
April 16, 1978, p. 11. Cited in Medical Care Review 35 (May 1978): 512. 

13. The Removal of Cadaveric Organs for Transplantation: A Code of Practice . 
Document drawn up by a Working Party on Behalf of the Health Departments of Great 
Britain and Northern Ireland. October 1979. 

14. "$3,000 Offer for Kidney Brings Man 100 Donors," New York Times , 
September 12, 1974, p. 36. 

15. Gene Outka, "Social Justice and Equal Access to Health Care," Journal of 
Religious Ethics 2 (Spring 1974): 11-32; James F. Childress, "Who Shall Live 
When Not All Can Live?" Soundings 53 (Winter 1970): 339-54. 

16. U.S. Health Care Financing Administration, "Exclusion of Heart Transplantation 
Procedures from Medicare Coverage," Federal Register 45 (August 6, 1980): 52296-97. 

17. President's Commission for the Study of Ethical Problems in Medicine and 
Biomedical and Behavioral Research, Securing Access to Health Care: The Ethical 
Implications of Differences in the Availability of Health Services . Vol. 1: Report 
(Washington, D.C.: U.S. Government Printing Office, March 1983), p. 4. 



351 

Mr. Gore. Dr. Childress, we are honored to have you here today. 
We invite you to proceed. 

Dr. Childress. Mr. Chairman and members of the committee, 
thank you very much for this opportunity to testify. 

So far, our society has failed to provide an adequate supply of 
organs that can be transplanted to save many lives, but this scarci- 
ty is not absolute, as we have heard today. Each year in the United 
States there are more than enough deaths, under conditions that 
would permit the salvage of organs, to provide a surplus of organs- 
there are approximately 20,000 such deaths. Unfortunately, most of 
those organs are wasted. 

It is not too difficult, as we have heard today, to secure organs 
for dramatic cases involving identified lives, such as Jamie Fiske, 
but not everyone can generate that publicity. It may be neces- 
sary—indeed, I think it probably is— to change our policies in order 
to increase the supply of organs for unidentified strangers. 

The question is whether we can increase the supply of organs for 
transplantation, which is an ethically desirable goal and, as Profes- 
sor Veatch has reminded us, is consistent with the Judeo-Christian 
tradition, without violating other important moral principles and 
values, such as respect for persons and their wishes and principles 
of justice or fairness in the distribution of benefits and burdens in 
the society. 

I want to concentrate on obtaining cadaver organs and then 
make a few comments about living donors before concluding by 
identifying some other problems that we need to face. 

First, cadaver organs. Currently, in all 50 States, under the Uni- 
form Anatomical Gift Act, individuals may sign a donor card to 
consent to the use of their organs after their deaths or their fami- 
lies may consent. 

Although there is a lot of controversy about this, according to 
the studies I have seen, very few people— the studies indicate be- 
tween 1.5 percent and 19 percent— ever bother to sign their donor 
cards. It may be very difficult for physicians to ask a family for 
permission or for the family to grant permission after the patient 
has died, if the patient has not earlier indicated his or her wishes. 

Several possible approaches have been suggested for obtaining 
cadaveric organs. The first would be to keep the Uniform Anatomi- 
cal Gift Act as it is, but to educate the public and to educate and to 
organize professionals in order to obtain more organs. 

I would agree with the emphasis on education of the public and 
education of professionals. It is not at all clear how effective this 
will be, but it will nevertheless be very important within any ac- 
ceptable policy. 

Regarding organization, the Centers for Disease Control studied 
the establishment of a recruitment network that over a 3-year 
period had a remarkable success rate of increasing the donation of 
organs by eight- or nine-fold. 

I think it is important to note in that particular study that ap- 
proximately 50 percent of the families who were asked to donate 
organs of their deceased relatives refused to give consent. Thus, in 
addition to organization, I think we will need to pay some attention 
to revisions in the Uniform Anatomical Gift Act. 



352 

Two such revisions might be considered. First, we might require 
a decision for or against organ donation of all adults. I don't think 
there can be a major ethical objection to this policy. It is consistent 
with principles of respect for persons and justice to require people 
to make a decision for or against donation. They would not be 
forced to decide for donation; they would only be forced to make a 
decision. 

Second, I would even be willing to consider from an ethical 
standpoint the possibility of moving to a system of presumed con- 
sent, ^ :_e so-called routine salvaging of organs or harvesting organs, 
except where there has been prior objection by the deceased person 
or where there is objection by the family. 

This is the system that has already been described as contracting 
out rather than contracting in. 
Mr. Gore. Opting out, I think. 

Dr. Childress. Both contracting out and opting out. Both terms 
are used interchangeably. 
Mr. Gore. Thank you. 

Dr. Childress. This is the practice in several countries, including 
Denmark, France, Israel, Italy, Norway, Spain, Sweden and Swit- 
zerland, among others. Sometimes this system of opting out or con- 
tracting out is combined with the use of donor cards and with at- 
tention to family objections. 

In the countries mentioned there are still some shortages of 
organs, but they come closer to meeting the needs, for example, for 
transplant kidneys than our own country does. 

I think all three approaches to obtain cadaveric organs are ethi- 
cally acceptable— the Uniform Anatomical Gift Act, requiring a de- 
cision, or presuming consent. They all seek a morally desirable goal 
without violating fundamental moral principles. 

Nevertheless, I agree with Robert Veatch that it would be ethi- 
cally preferable to keep the Uniform Anatomical Gift Act, the 
policy of giving and receiving that emphasizes voluntary generosity 
and altruism, other things being equal. But I think that this policy 
has not proved to be adequate to meet our needs. 

Next in rank order, but still ethically acceptable, would be a 
policy of requiring a decision and finally a policy of presuming con- 
sent. I would emphasize that I believe they are still ethically ac- 
ceptable even if the Uniform Anatomical Gift Act is preferable. 

Then I think we should consider which one of these might be the 
most effective and efficient in obtaining organs as long as, again, 
we are not violating fundamental ethical principles. It would, how- 
ever, be ethically unacceptable simply to take organs without 
regard to prior wishes or current objections. No one really proposes 
that. 

A few comments about living donors, who are especially impor- 
tant in kidney transplantation and bone marrow transplantation. 
For example, in renal transplantation approximately 30 percent of 
the kidneys come from living donors, most often living-related 
donors. 

In general, the trend over the last several years away fom the 
use of kidneys from living donors is to be applauded because it 
avoids risks to healthy persons. But in some situations living 
donors, especially related living donors, may be the best sources, if 



353 

we can be sure that those donors are competent to consent, are in- 
formed, and are choosing voluntarily. To exlude them categorically 
would be unwarranted paternalism. Yet, a policy of obtaining or 
seeking cadveric kidneys wherever possible is morally preferable. 

In my written testimony, I discussed two classes of family mem- 
bers who are especially problematic as donors: Preadolescent chil- 
dren and mentally retarded persons. I will not discuss them here. 

Let me make one comment about living, unrelated donors. Few 
kidneys from such donors have been accepted since 1970, perhaps 
because of a widespread suspicion that such persons are unbal- 
anced because they want to make such a donation to people who 
are not their relatives and who are perhaps even strangers. 

Yet, some polls indicate that approximately half of the people in- 
terviewed think that there is an even chance that they would 
donate a kidney to a stranger while they are alive. So, I think we 
should not categorically exclude such individuals if, again, they are 
competent, informed, and choosing voluntarily. 

Regarding the sale of organs from living donors or from newly 
dead persons, neomorts as they are sometimes called, I think it is 
important to note that the sale of organs is not clearly prohibited 
in most states. It has been reported in other countries, and there 
are advertisements, as already noted, in many places in the United 
States. 

I think that the sale of organs should be prohibited for the rea- 
sons that Professor Capron indicated, especially to prevent abuses 
and to prevent exploitation in a society with great differences in 
the distribution of wealth. 

Finally, let me identify a couple of problems that need further 
attention. 

First, people frequently do not sign their donor cards because of 
forgetfulness. Furthermore, less than 20 percent of the population 
at large have wills when they die. I think that in the area of organ 
donation there is also the element of fear and distrust of medical 
professionals and institutions, fueled perhaps by such movies as 
Coma. There is a fear of being declared dead prematurely in 
order to benefit others. 

I am not sure that the educational and organizational procedures 
suggested earlier or the changes proposed in the Uniform Anatomi- 
cal Gift Act would really reduce fear and distrust. I am not sure 
how this can be done, but I think it is an important problem if we 
are really going to increase the supply of organs. 

Mr. Gore. Doctor, I think that is an important problem, too. 
Even if it is often unstated or unarticulated, I think that is in the 
back of the mind of a lot of people who use it not as a factor in 
making an explicit decision but as almost an unconscious factor in 
deciding not to decide, in not facing the question because of that 
lingering doubt or fear. 

Do you agree with that? 

Dr. Childress. I do, indeed. Earlier this week I was making a 
presentation at the West Virginia University Medical Center and 
had a chance to talk to several chaplains who are involved not only 
in hospital care, but also in local congregations. They have faced 
such problems with members of their religious communities, and 



354 

they reported that fear and distrust emerge again and again in the 
reservations their parishioners have about organ donation. 

Mr. Gore. Yesterday we heard some statistics showing that ac- 
cording to the National Kidney Foundation's new Gallup poll, the 
percentage for black Americans who felt like they might become 
donors was just half that of the percentage of white Americans. 

It occurred to me at that time that the historical and traditional 
view of society's institutions that is unique to the black community 
might have contributed to that feeling that we were just discussing 
and might account for the dramatic difference in the polling re- 
sults. 

Dr. Childress. I think that is a very important observation. It 
would be interesting to know if other people who feel themselves 
similarly on the margins of society, perhaps economically dispos- 
sessed, would have similar reservations or little confidence in the 
medical profession and institutions in society. 

Mr. Gore. It seems to me that as the medical community decides 
how it is going to approach this question — and some of the doctors 
here yesterday said that the medical community itself has to do a 
great deal more — it ought to at least consider how it might address 
that lingering fear and come up with some sort of absolutely fail- 
safe guarantees that there will be no basis whatsoever for those 
fears and get that message out. It might really be a bottleneck in 
holding back the solution to this problem. It is something that I 
think is worth a good deal of attention. 

Dr. Childress. I think so, and the mere provision of information 
that I talked about under the heading of education would not be 
sufficient. Something else has to occur. We might note that histori- 
cally the move to update the criteria for determining death was in 
part influenced by the need to obtain organs for transplantation. 
That influence was enough to create some suspicion and distrust on 
the part of individuals. 

Mr. Gore. There is a movie out now, I haven't seen it yet, and I 
don't know if anyone has seen the new Monty Python movie. Often 
humor plays on some unconscious fears. I am told, although I 
haven't seen it, that one of the skits in the movie is someone walk- 
ing up and asking individuals if they have an organ donor card. 
When they respond positively, the character pulls out a gun and 
shoots him right on the spot. This is presented as a humorous skit 
in this movie. 

The reason it is humorous I think probably has to do with this 
lingering attitude that probably does play a significant role here. 

Please go ahead. 

Dr. Childress. I will finish with some comments about one more 
problem; that is the problem of the allocation of society's resources 
and the allocation of scarce organs. Professor Capron raised this 
issue. I am not sure where I come down on this issue, but I would 
agree with him that it is complicated and needs the most careful 
attention. 

For example, society now provides practically universal coverage 
for renal dialysis and renal transplantation. That decision was 
made in the early seventies, and now a lot of people are raising 
questions about whether our society can afford the tremendous 
costs of the program. 



355 

I would suggest that in all of these areas of technology and trans- 
plantation it is important to ask the question about how society's 
scarce resources should be allocated, for example, as Professor 
Capron suggested, between health care and other goods. 

But also, within health care, should we concentrate on technol- 
ogies for cirtical care or chronic care, or should we concentrate on 
prevention? It seems to me that this is the kind of question that 
would have to be faced in an overall societal policy about health 
care because we might be able to save more lives statistically in 
the long run if we concentrated on prevention rather than on some 
forms of critical care. This issue would have to be settled at on a 
case-by-case basis. 

It is important to build on the kind of compassion you described, 
but also to see how that compassion has to be filtered through a 
perspective that considers the whole range of health problems in 
the society and statistical as well as identified lives. 

In terms of the other part of the allocation question — the alloca- 
tion of organs to recipients when the supply is limited — I think 
that we probably have had fewer problems in this area than in the 
allocation of artificial organs partly because to allocate organs for 
transplantation it is necessary to get a good match, that is, to look 
at the medical need, but also to look at the probability of a success- 
ful transplant. Thus, there is a tendency to emphasize medical cri- 
teria. 

I think that these criteria are important and acceptable, but 
when we have to move beyond medical criteria, as Professor 
Veatch has rightly indicated, we should not make judgments of 
social worth or social value. We should rather use some form of 
randomization or queuing or "first come, first served" in order to 
build in a kind of equality of opportunity that respects persons as 
persons and accords them equal value. 

Thank you very much. 

[The prepared statement of Dr. Childress follows:] 



356 



The Gift of Life: Ethical Problems and Policies in Obtaining 
Organs for Transplantation 

James F. Childress 
Professor of Religious Studies and 
Professor of Medical Education 
University of Virginia 
Charlottesville, Va. 22903 

Several transplanted organs and tissues can increase a 

recipient's chances of survival or improve a recipient's quality 

of life. Yet the supply of organs and tissues is inadequate to 

meet the need and demand for transplantation. Enough cadaveric 

organs exist, but the society has not yet found an effective, 

efficient, and morally acceptable way to obtain them. The 

Council of Scientific Affairs of the American Medical Association 

has helpfully described our situation: 

Organs removed from a cadaver after breathing and 
heart action have ceased have sustained serious ischemic 
injury and, except for cornea, bone, and skin, are 
rarely suitable for transplantation. Death from 
brain injury, tumor, or infraction may permit hours 
or days of normal circulation, especially if controlled 
mechanical ventilation is maintained, which will allow 
preservation of heart and kidney until they can be re- 
moved, cooled, and properly preserved for transplantation. 
There are more than enough deaths in the United States 
(estimate, 20,000) to provide a su rfeit of organs, if 
tEere were a satisfactory method of bringing a ll sucn 
cadavers into the pool of donors . Now that tnere is a 
cadaver graft survival of transplanted hearts or kidneys 
of 50% to 70% and kidney host survival of up to 90% for 
two years, it has become important that our society find 
ways to improve donor recruitment. 1 



357 



Such a dramatic case as Jamie Fiske's can temporarily direct 
the public's attention to the need for organs. Many potential 
donors respond enthusiastically to dramatic cases involving 
identified lives , but changes in public policies may be necessary 
to increase the supply of organs for unidentified strangers . 
Some changes in policies can be expected to increase the supply 
of organs and tissues and can be implemented without violating 
important ethical principles and values. 

Currently in all fifty states the Uniform Anatomical Gift 

Act allows us to determine what will be done with our organs 

donor 
after our deaths. If we do not sign a / card, available in many 

states with the driver's license, our families may consent to 

donate our organs after our deaths. According to some opinion 

polls, as many as 70% of the adult population say that they are 

willing to have their organs used for transplantation after they 

die, but very few (between 1.5% and 19%, according to some 

2 
studies) actually sign donor cards. Furthermore, families 

frequently find it very difficult to donate organs after the 

death of a loved one, and physicians and other health care 

professionals may be reluctant to raise the question of organ 

donation.^ In this situation, which policies might increase the 

supply of organs - a morally desirable goal - without violating 

other moral principles and values? 

In assessing various policies, I will emphasize the following 

moral principles and values: (1) Not harming others (sometimes 

called the principle of nonmalef icence) ; (2) Benefitting others 

(sometimes called the principle of beneficence); (3) Producing 



358 



the greatest good for the greatest number (sometimes called the 
principle of utility); (4) Distributing benefits and burdens in 
a fair or equitable way (sometimes called the principle of justice) ; 
and (5) Respecting personal wishes, choices, and actions (sometimes 
called the principle of autonomy or the principle of respect for 
persons). I cannot argue for these principles here, but they are 
widely accepted as morally relevant to an assessment of actions, 
practices, and policies in science, medicine, and health care. 
They can be discerned in various deliberations about policies; for 
example, they appear (in somewhat different form) in the 
deliberations of the National Commission for the Protection of 
Human Subjects of Biomedical and Behavioral Research. Proposals 
to change policies in order to increase the supply of organs 
usually appeal to principles #1, 2, and 3, particularly utility. 
Arguments against such policies frequently appeal to principles 
#4 and 5, particularly autonomy or respect for persons. Thus, 
while all of these principles are relevant to the policies under 
consideration, I will concentrate on utility and autonomy or 
respect for persons . 



359 



I will argue that an effective and efficient system for obtaining cadaveric 
organs (organs from the "newly dead" or "neomorts") can reduce and perhaps even 
eliminate scarcity without violating other principles such as justice and re- 
spect for persons. Within the range of ethically acceptable systems of organ 
procurement, some may be ethically preferable or ideal without being mandatory. 
It may be ethically preferable to retain our current laws regarding organ do- 
nation and to reduce scarcity through educational and organizational efforts. 
But such educational and organizational efforts, which would be expensive, would 
probably need to be supplemented by changes in the Uniform Anatomical Gift Act. 
It would be ethically acceptable to (a) require each adult to make a decision 
about the use of his or her organs after death, or (b) to presume consent to 
organ removal after death unless the person has previously registered his/her 
dissent or his/her family dissents. It would be ethically unacceptable simply 
to take organs from the decedent without regard to the decedent's prior wishes 
or the family's wishes. After considering ethically acceptable approaches to 
obtaining cadaveric organs, I will examine policies regarding living donors. 

Cadaveric Organs : Educational and Organizational Efforts 
within the Current Legal Structure 

^ Education of the public . Policies of educating the public about the need and 
importance of gifts of life should not be underestimated. Some people fail to 
sign their donor cards because of forgetfulness; others may mistrust medical 
institutions and professionals, fearing that they will be declared dead pre- 
maturely so that their organs can be retrieved for others. There is a clear 

the 
need for educational activities that would alert the public to/need for organs 

and explain the whole process, including the determination of death. Nevertheles 

such educational activities cannot be expected to reduce scarcity significantly 

without other changes. 



360 



Education and Organization of Physicians and Other Health Care Pro- 
fessionals. Physicians and other health care professionals need to be 
educated about the need for organs for transplantation so that they will 
actively seek to increase the supply. It is not easy for physicians who 
have "lost" a patient to start thinking about how that dying or dead 
patient's "parts" might benefit others. Nevertheless, once it is clear 
that the patient will not survive or is brain dead, the neurosurgeons and 
neurologists (who see most potential donors) should actively seek to benefit 
other patients by alerting the appropriate team. As some commentators have 
argued, "the only goal of the neurosurgeon must be the full treatment of 
a potentially salvageable patient, /~but_7 once brain death has occurred 
a more general responsibility become operant, namely to identify potential 
donors and avoid wastage of organs . " -* 

This educational activity needs to be combined with organizational 
activities to increase the identification of potential donors and to 
arrange transplantation. The value of organizational activities can be 
seen in the study of a group of physicians at the Centers for Disease 
Control in Atlanta. These physicians organized a "recruitment network" 
to relate the transplant team to certain hospital areas, such as the 

intensive care units, through a transplant nurse -coordinator. During 

6 
the 2 l/2 year study, the number of actual donors increased by ninefold. 

Obviously, both educational and organizational activities are expensive. 

Successful efforts will be costly, and they will presuppose some judgments 

about priorities in the allopation of resources within the health care system. 

It would be inadequate to undertake one effort without the other. For example 

7 
in the CDC study, family consent was received only about half of the time. 

Hence it is necessary to combine education of the public with education and 

organization of health care teams. But both would be more effective if 

donor laws required a decision about donation by all adults or presumed 

consent from adults who have not objected (or whose families do not object). 



361 



Cadaveric Organs : Changes in the Uniform Anatomical Gift Act 
Two possible changes in the Uniform Anatomical Gift Act merit careful 
attention; either could help to increase the supply of organs for transplantation 
without violating principles of justice or respect for persons. 

Requiring a decision . If few donor cards are signed because of inadvertence 
or f orgetf ulness , the law could be changed to require everyone above a certain 
age to make a decision for or against the use of his/her organs after death. 
Our society rightly wants to avoid making people decide to donate their organs, 
but there is no ethical objection to requiring them to make a decision for or 
against such donation. Obviously, such a change in state laws might not 
lead to a dramatic increase in affirmative decisions about organ donation without 
the educational efforts mentioned above. Furthermore, the increased use of 
organs would depend on increased professional activity and organization. But 
in conjunction with efforts to educate the public and to educate and organize 
physicians and others, this change in legislation could be very effective. And 
it does not violate standards of justice and respect for persons; indeed, 
personal wishes and choices are determinative. 

Presuming consent (sometimes called "routine salvaging of organs" or 
"harvesting organs"). Both the Uniform Anatomical Gift Act and a law requiring 
a decision involve "contracting in," and both should be ranked above this system 
of "contracting out."° But a system of presumed consent is not ethically unacceptable. 
Recognition of presumed consent (or tacit consent) as the basis for organ removal 
after a person's death does not violate principles of justice and respect for 
persons, if that person had an opportunity to dissent. It has been argued that 
"presumed consent would ... be in keeping with traditional humanist values by 
making the basic presumption one that favors life and by putting the burden of 
objecting upon those who would deny life to another. The policy of saving human 
life would be given first priority, yet the wishes of persons to preserve a 



362 



9 
corpse inviolate would also be accommodated." In short, presumed consent 

(or tacit consent) enables the society both to realize utility and to respect 

persons. Even though presumed consent would not emphasize voluntary gifts 

(as in the Uniform Anatomical Gift Act or a statute requiring a decision), it 

would not authorize actions against a person's express wishes. 

Presumed consent laws exist in a number of countries, including Denmark, 

France, Israel, Italy, Norway, Spain, Sweden, and Switzerland. In approximately 

h alf of the countries with presumed consent statutes, physicians also determine 

whether the family has an objection to organ removal. Some countries recognize 

10 
both donor cards and presumed consent. 

How effective are presumed consent laws in reducing scarcity of organs 

for transplantation? All countries with presumed consent laws still have 

waiting lists for renal transplantation, but they "seem to come closer to meeting 

their needs for transplant kidneys . Presumed consent will probably not be 

effective without vigorous efforts to educate physicians and other health 

care professionals and to organize procurement of organs. It will not be 

ethically acceptable without education of the public about the options, and 

widespread objections ("opting out") can be expected unless the public realizes 

the need for organs and trusts the medical profession and institutions. Finally, 

at least in the United States, a policy of presumed consent ought to be combined 

with donor cards and family approval. But a policy of presumed consent 

should make it easier to seek and to gain family approval. 



363 



Living Donors 

So far I have concentrated on cadaveric organs, examining 
current and possible policies to increase the supply of such organs 
and ranking those policies according to several moral principles. 
But for some tissues and paired organs, such as kidneys, it is 
possible to use living persons as donors. Some recent controversial 
cases have involved bone marrow transplantation. In one such 
case a judge refused to order a man to complete the tests he 

had started and to donate bone marrow to save his cousin's life 

12 
if he proved to be histocompatible. The principle of respect 

for persons, and derivative rules such as privacy, dictate a 

policy of not removing tissues or organs from a person's body 

against that person's will even to save someone else's life. 

This principle is recognized in both morality and law. It is 

sometimes interpreted to permit removal of organs from an incompetent 

person, such as a minor or retarded person, but often in those 

cases the explicit rationale is that the "donor" will also benefit 

(e.g., by not losing a close sibling). In such cases, proxy 

consent is required. 

In the area of renal transplantation, there has been a clear 

trend to accept fewer donations from living persons. For example, 

in 196 7, 56% of the transplanted kidneys came from cadavers, while 

13 
in 1973, 70.4% came from cadavers. That trend has continued. 

Qn the one hand, that trend should be applauded insofar as it 

avoids risks to the health of living donors and risks of 

manipulation and coercion within a family to get a reluctant donor 



364 



to give a kidney to a family member. On the other hand, that 
trend may represent unwarranted disrespect for a potential 
donor's wishes and choices, which may be adequately informed 
and voluntary. 

The reluctance to use living donors may stem from beliefs 
about the risks of kidney donation, from worry about the lack of 
understanding and voluntariness of potential donors, and from 
fear of malpractice suits. Removing a kidney from a living 
donor is an atypical medical procedure: It is performed to provide 
medical benefit for another patient, not for the donor himself 
or herself. Thus, the risk-benefit calculus mainly involves 
medical risks for the donor and medical benefits for the recipient 
(though there may, of course, be nonmedical benefits for the donor 
and medical risks for the recipient) . While kidney donors 
accept risks from the surgical removal of a kidney as well as from 

living with only one kidney, their survival rates do not appear 

14 
to differ from those of nondonors. Furthermore, a competent 

and informed donor may voluntarily accept such risks without 

paternalistic intervention. Of course, many potential living 

donors may be incompetent to consent to such a procedure or may 

be under severe pressure and even coercion especially within a 

generally 
family context. Such persons/ should not be accepted as donors, ,j 

C 

N Where the risks are minimal 

to a particular donor, who is competent, informed, and willing 
to donate, a signed consent form should be sufficient to protect 
the physician from a malpractice suit. 



365 



10 



While these points hold, in general, for both living related donors and 
living nonrelated donors, it is useful to distinguish the two groups. 

Living related donors . In general, "donor grafts from siblings and 
parents show superior functional success over cadaver grafts.' ^ But this 
source could not meet the need for kidneys in the population: "Eighty per cent 
of potential recipients have relatives who are unsuitable donors because of 
antigenic incompatibility, kidney disease, and renal anatomical problems . "^ 
Thus, living related donors constitute an important but insufficient source 
of kidneys for transplantation. 

The major ethical concerns about living related donors who are competent 
to consent focus on their understanding of the risks and their willingness to 
undergo the surgical procedure and to accept the risks. Some studies show that 
family members frequently decide to donate a kidney when they hear that a 
relative needs one, even before they have been informed about the risks. 
Furthermore, such donors frequently use the language of "necessity" to describe 

their choice: "I could not have lived with myself if I had failed to donate," 

27 
or "I had no choice.' Neither deciding before being informed nor using the 

language of necessity invalidates the consent. The donors may have decided 

that their reasons for donating (e.g., to save a relative's life) outweighed 

the risks that were disclosed to them, and their languags of necessity may 

simply indicate the importance of their reasons for donation. Of course, 

judgments about the adequacy of a donor's information, understanding, and 

voluntariness can only be made in the situation, and professionals need to be 

sensitive to inadequacies on any of these levels, perhaps especially to subtle 

signs of coercion from other members of a family. In such settings, physicians 

sometimes provide a "medical excuse" for potential donors under severe 

-I Q 

external pressure to donate. 



23-029 0-83-24 



366 



li 



Two classes of living related donors are especially controversial because 
their autonomy is seriously limited and even nonexistent in some cases: 
children (especially preadolescent children) and mentally retarded persons. 
Because of the limitations on their capacity to give valid consent, it may 
be unjust to impose the burdens and risks of kidney removal on them in order 
to benefit some other member of the family. The counterargument is that even 
though children and mentally retarded persons lack the capacity to give valid 
consent to organ removal, they can sometimes assent to (or dissent from) such 
a procedure, and, more importantly, they frequently derive significant nonmedical 
benefits from "organ donation." These benefits may result, for example, from 
the survival of a family member who contributes greatly to the "donor's" 
well-being and happiness .^ There are reasons to be suspicious of claims 
about such benefits in many cases, but it is unclear to me whether all uses 
of children or mentally retarded persons as "organ donors" for other members 
of the family should be categorically prohibited. At the very least, there 
should be independent, judicial review of the proposal to remove an organ 
from such an incompetent, dependent, and vulnerable person. This review 
should determine whether the heavy presumption against using such a person 
as a "donor" can be rebutted, perhaps because of significant nonmedical benefits 
to him or her. 

Living nonrelated donors . There has also been a trend away from the 

use of living nonrelated donors. Since 1970 few kidneys have been obtained 

20 
from living nonrelated donors for transplantation. Apparently there is a 

suspicion that people who want to donate a kidney to an unrelated person, 

perhaps even a stranger, are mentally unbalanced. Nevertheless, according 

to one poll, only k6% of those surveyed thought that there was less than an 

even chance that they would donate one of their kidneys to a stranger in need; 

only 2k% definitely ruled it out. 21 Polls are notoriously unreliable, and there 

is often a conflict between what people say they would do and what they actually 



367 



12 

do. But such evidence suggests that living nonrelated donors need not be 
categorically excluded. Decisions about their acceptability 
should be made on a case -by-case basis. 

The sale of organs . On occasion, the media present dramatic stories of 
people wanting to sell organs, such as kidneys and cornea, in order to raise 

money for themselves or for their families. The sale of organs has been re- 

22 

ported in some countries, and it does not appear to be illegal in most states. 

Earlier studies indicated that a policy of buying and selling blood is in- 

23 
efficient and increases risks for the recipient. There may be good reasons 

to prohibit the sale of bodily parts. Many of these reasons concern justice, 

respect for persons, and the society's sense of itself. For example, it is 

sometimes argued that prohibition of the sale of - organs is necessary to prevent 

exploitation in a society of great differences in the distribution of wealth. 

Serious abuses could be expected in a system of buying and selling organs, 

whether from one ' s own body or from cadavers . 

Conclusions 

The scarcity of organs for transplantion is not absolute. Each year enough 
people die under conditions that would permit the salvage of enough organs to 
meet the needs for transplantation. Utility would dictate changes in policies 
to obtain more organs, and such changes can be made without sacrificing other 
important moral principles such as justice and respect for persons. 

First , there should be efforts to increase the supply of cadaveric organs , 
but living related and nonrelated donors, who are competent, informed, and 
acting voluntarily, should not be excluded in such areas as kidney donation. 
Second, a system of taking organs without regard for the wishes of the decedent 
and his/her family is ethically unacceptable as a violation of the principle of' 



368 



13 



respect for persons. Third, the principles of justice and respect for persons 
require caution and perhaps even prohibition of the use of children and 
mentally retarded persons as "donors," even when they stand to gain nonmedical 
benefits. At the very least, strong procedural standards should be required. 
Fourth, there are good reasons to be suspicious of the sale of bodily organs 
and perhaps even to prohibit it altogether. 

Concentrating on the most important source of organs — cadavers — I 
argued that a multifaceted approach is required. Whether we retain or modify 
the Uniform Anatomical Gift Act, more education of the public and medical 
professionals is essential, and improvements in organization are required. 
Public funds should be allocated for these measures. Even if the Uniform 
Anatomical Gift Act is morally preferable (ceteris paribus) because of its 
emphasis on voluntary giving, it is morally acceptable to change state laws 
to (a)require a decision for or against donation, or (b) presume consent for organ 
donation in the absence of a prior dissent or familial dissent. All three 
approaches — the Uniform Anatomical Gift Act, requiring a decision, and 
presuming consent — satisfy the criteria of justice and respect for persons. 
Which one should be adopted will thus depend on an assessment of utility. 



369 



Notes 

1. Council on Scientific Affairs, "Organ Donor 
Recruitment," Journal of the American Medical Association 
246 (Nov. 13, 1981) : 2157. 

2. Howard H. Kaufman, et al., "Kidney Donation: Needs 

and Possibilities," Neurosurgery 5 (1979): 237, 240; Frank P. Stuart, 
Frank J. Veith, and Ronald E. Cranford, "Brain Death Laws 
and Patterns of Consent to Remove Organs for Transplantation 
from Cadavers in the United States and 28 Other Countries," 
Transplantation 31 (1981): 239. It has also been noted that 
more than 80% of all decedents leave no wills. 

3. Stuart, Veith, and Cranford, "Brain Death Laws...." 
p. 240. 

4. These principles have been defended in Tom L. Beauchamp 
and James F. Childress, Principles of Biomedical Ethics (New York: 
Oxford University Press, first ed. , 1979, second ed. , 1983). 

See also the National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research, The Belmont 
Report: Ethical Guidelines for the Protection of Human Subjects 
of Research . DHEW Publication No. (OS) 78-0012 (1978), which 
emphasizes principles of beneficence (includinq nonmalef icence 
and utility) , justice, and respect for persons. 

5. Kaufman, et al., "Kidney Donation: Needs and 
Possibilities," p. 237. 

6. Council on Scientific Affairs, "Organ Donor 
Recruitment," p. 2158; Kenneth J. Bart, et al., "Increasing 
the Supply of Cadaveric Kidneys for Transplantation," 
Transplantation 31 (1981): 383-87. Slightly different figures 
are given in the two papers. 

7. Bart, et al., "Increasing the Supply of Cadaveric 
Kidneys for Transplantation," p. 385. 

8. For some of the debate, see Paul Ramsey, The Patient 
as Person (New Haven: Yale University Press, 1970) , chap. 5 , 
which argues that a policy of organized giving and receiving 

is better than a policy of taking, and James Muyskens "An Alternative 
Policy for Obtaining Cadaver Organs for Transplantation," 
Philosophy and Public Affairs 8 (1978) : 88-99. There is also 
vigorous debate in the United Kingdom. See Ian Kennedy, "The 
Donation and Transplantation of Kidneys: Should the Law Be 
Changed?", Robert A. Sells, "Let's Not Opt Out: Kidney Donation 
and Transplantation," and Ian Kennedy, "Kidney Transplants: A 
Reply to Sells," Journal of Medical Ethics 5 (1979) : 13-21 and 
165-69; 6 (1980) : 29-32. 

9. Stuart, Veith, and Cranford, "Brain Death Laws...." 
p. 238. 

10. Ibid . , p. 239 

11. Ibid. 



370 



12. McFall v. Shimp , Allegheny County Ct. Common Pleas, 
10 Pa. D & C 3d 90. Excerpts appear in Michael H. Shapiro 
and Roy G. Spece, Jr., Bioethics and Law : Cases , Materials 
and Problems (St. Paul, Minn.: West Publishing Co., 1981), 
pp. 819-20. 

13. See Kaufman, et al., "Kidney Donation: Needs and 
Possibilities," p. 238 (plus references). For some discussion 
of the issues, see R. L. Lawton, "Living Nonrelated Donors for 
Transplantation," Proc. Dialysis Transplant Forum (1978): 30-34; 
L. Kamstra-Hennen and R. G. Simmons, "Ethics of Related Donation: 
The Unsuccessful Case," Proc . Dialysis Transplant Forum (1978): 
25-29; Carl H. Fellner and Shalmom H. Schwartz, "Altruism in 
Disrepute: Medical versus Public Attitudes toward the Living 
Organ Donor," New England Journal of Medicine 284 (March 18, 
1971): 582-85. 

14. Dorothy M. Bernstein, "The Organ Donor," Journal of 
the American Medical Association 237 (June 13, 1977) : 2643. 

15. Ibid . 

16. Kaufman, et al., "Kidney Donation: Needs and 
Possibilities," p. 238. 

17. Carl H. Fellner and John R. Marshall, "Kidney Donors: 
The Myth of Informed Consent," Amer . J. Psychiat . 126 
(March 1970) : 1245-51, and Robert M. Eisendrath, Ronald D. 
Guttmann, and Joseph E. Murray, "Psychologic Considerations in 
the Selection of Kidney Transplant Donors," Surgery , Gynecology 
and Obstetrics 129 (August 1969): 243-48. 

18. Bernstein, "The Organ Donor," p. 2644. 

19. For some of the issues, see Paul Ramsey, The Patient 

as Person ; Norman Fost, "Children as Renal Donors," New England 
Journal of Medicine 296 (Feb. 17, 1977): 363-67; Norman K. 
Hollenberg, "Altruism and Coercion: Should Children Serve as 
Renal Donors?" New England Journal of Medicine 296 (Feb. 17, 
1977) : 390-91; John A. Robertson, "Organ Donations by 
Incompetents and the Substituted Judgment Doctrine," Columbia 
Law Review 76 (1976): 48-78; Dorothy M. Bernstein and Roberta 
G. Simmons, "The Adolescent Kidney Donor: The Right to Give," 
Am. J. Psychiatry 131 (December 1974): 1338-43. 

20. "Live unrelated donors are generally not considered, 
although there is a minority opinion about this subject, even 
when children may be involved." Kaufman, et al., "Kidney Donation: 
Needs and Possibilities," p. 238, For a minority opinion, see 
Lawton, "Living Nonrelated Donors for Transplantation," 

21. Fellner and Schwartz, "Medical versus Public Attitudes 
toward the Living Donor," p. 583. 

22. See Jim Brooke, "Kidney, Cornea Sale Flourishes in 
Brazil," Washington Post 10/12/81; Stuart, Veith, and Cranford, 
"Brain Death Laws...." p. 241; Shapiro and Spece, Bioethics and 
Law , pp. 823-28; Marvin Brams, "Transplantable Human Organs: 
Should Their Sale Be Authorized by State Statutes?" American 
Journal of Law and Medicine 3 (1977): 183-195; Clifton Perry, 
"Human Organs and the Open Market," Ethics 91 (October 1980): 

6 3-71; and Ramsey, The Patient as Person . Ramsey opposes the 
sale of organs, while Brams and Perry argue for policies and 
laws authorizing such sales. 

23. Richard Titmuss, The Gift Relationship (New York: 
Pantheon, 1971) . 



371 

Mr. Gore. Thank you very much. I find your testimony really 
very helpful and thought provoking. 

You two disagreed on the opting out system. In other words, we 
now have the system where you can choose to be an organ donor 
and if you don't make a choice, then it is assumed that you are not 
an organ donor. 

There have been two proposals, among others. One is to set up a 
system that confronts everyone with the necessity of choosing yes 
or no without any coercion to make one choice or another, leaving 
aside the question of whether or not there is a subtle coercion at- 
tached to the forcing of the question. 

I take it that both of you would think that system passes ethical 
muster. Is that correct? Dr. Veatch? 

Dr. Veatch. I am not sure the extent to which we disagree. 

Mr. Gore. I am going to get to the other scenario after this one. 
This is the forcing of the choice. Dr. Childress went even further 
and endorsed an opting out system, but let me hold that one up. 

Dr. Veatch. I would favor forcing a response. 

Mr. Gore. Forcing a response. 

Dr. Veatch. I think a yes-no forced choice may be more than 
people are prepared to make at this time. Yes, no and undecided 
would be satisfactory. I would like to see that on our income tax 
forms, or whatever we distribute regularly and store information 
in a computerized fashion. 

Mr. Gore. We might have to investigate what effect that might 
have on tax evasion. [Laughter.] 

Dr. Childress goes even further and says that in his view, it 
would be ethically permissible to assume that people would wish 
their organs donated absent an affirmative decision to say no. 

You have a real problem with that, right, Dr. Veatch? 

Dr. Veatch. I think there are real problems with that. Again, I 
was attempting to summarize the positions taken by the major 
churches and major theologians working with the churches. 

There has been historically a problem with the salvaging or 
opting out schemes. For example, we have a history, in some of the 
earlier cases, of organs being taken without familial or patient con- 
sent and then discovering only too late that there were family 
members available who would have objected. I think the opting out 
scheme creates an incentive for the system to fail to get donations 
recorded efficiently, seek out relatives when there is no indication 
of a donation. 

I would prefer to maintain those incentives as long as possible to 
make the donation system work. Only if we discover that the dona- 
tion system and the forced choice systems didn't do the job should 
we begin to consider ethics of the salvaging schemes. Quite frankly, 
I see serious problems in them. 

Mr. Gore. Dr. Childress? 

Dr. Childress. I think Professor Veatch is right. We probably 
don't disagree as much as it first appeared because we both agree 
on the ranking of the systems, with the Uniform Anatomical Gift 
Act at the top, as the preferable system; then a system of forced 
decision, and then a system of presumed consent. 

Where we differ I think is in our assessment of how soon, if ever, 
we might need to move away from the Uniform Anatomical Gift 



372 

Act to one of the other systems. It may in part have to do with a 
judgment about need and a judgment about effectiveness. 

I think we do perhaps disagree at one point, though. I understood 
Professor Veatch to suggest that the religious traditions have more 
unanimity or uniformity of disagreement with a policy of presumed 
consent than I think is actually the case. 

I do not have a record of the opposition in the countries men- 
tioned, but I think it is interesting to note that Israel is among the 
countries with a system of presumed consent, along with a number 
of other countries that pay a fair amount of attention to religious 
values. 

It may well be that Professor Veatch is reflecting the individual- 
ism of most writers in the United States who work within theologi- 
cal contexts. It is the case that no English-speaking country, to my 
knowledge, has adopted presumed consent; this may reflect the tra- 
dition of individualism more than the religious traditions to which 
he referred. 

Mr. Gore. We were unable to locate any data showing the suc- 
cess of organ donation in countries with presumed consent systems. 
You know of no such data, do you? 

Dr. Childress. There is some information. 

Mr. Gore. Would you provide that to the subcommittee? We 
have conducted a rather thorough search. There is some sketchy 
data, but we would like to have your thoughts on that as well. 

Dr. Childress. It is not wholly adequate, but I would be glad to. 

[The information follows:] 

Without providing the statistics, one study notes that "countries with presumed 
consent seem to come closer to meeting their needs for transplant kidneys." (Frank 
P. Stuart, Frank J. Veith, and Ronald E. Cranford, "Brain Death Laws and Patterns 
of Consent to Remove Organs for Transplantation from Cadavers in the United 
States and 28 Other Countries," Transplantation 31 (1981): 239). 

Mr. Gore. I will now recognize Congressman Reid. 

Mr. Reid. Mr. Chairman, I have no questions. Thank you. 

Mr. Gore. Dr. Veatch, in this week's issue of the Journal of the 
American Medical Association you made some very interesting re- 
marks. 

One was, "If children are receiving or not receiving liver trans- 
plants because of funding allocation decisions, then that is the kind 
of insurance debate that the public ought to know about and par- 
ticipate in." 

Could you elaborate on this for us? 

Dr. Veatch. I am concerned — and I think we have seen evidence 
of it in the Fiskes' comments — that rather subtle, behind the 
scenes judgments, either by government insurers or more often by 
private insurers, in effect determine whether or not a life-saving 
transplant takes place. 

I would concur with Alex Capron in acknowledging that there 
are some services that simply cannot be included in insurance 
schemes, whether they be public or private. The decision to include 
or exclude it seems to me must meet two criteria: 

First, it must meet the criteria of fairness. If some people are in- 
cluded, all people equally in need ought to be included as well. 

Second, it has to meet what in the jargon of philosophy might be 
referred to as the criterion of publicity. The public needs to partici- 



373 

pate actively in the judgment. We need to ask ourselves as a soci- 
ety, do we want an insurance scheme that will cover liver trans- 
plants or kidney transplants. As a collectivity, we should under- 
stand that it is going to cost money for that insurance scheme if we 
cover those services, just the way dialysis costs the government 
money. 

Mr. Gore. That is unclear in this case, however. We ought to 
eliminate the disagreements over that because the evidence indi- 
cates in some cases it is actually cheaper 

Dr. Veatch. If it turns out to be cost effective to cover a medical 
service, then it is common sense. By every criterion you could 
imagine you would cover it. 

The interesting cases are those where a service will be beneficial, 
often only marginally beneficially, add months to a life or add a 
year or two to life with suffering, perhaps, but at substantial cost. 

For that kind of a question, it seems to me that, rather than in- 
surance company bureaucrats or even those within the bowels of 
HHS making decisions about medicare-medicaid funding, the 
public as a whole needs to participate fully and actively and decide 
what gets covered. Once the decision is made, either everyone gets 
covered or no one gets covered. 

Mr. Gore. Dr. Childress, you recommended a legal prohibition on 
the sale of organs and body parts. You don't think that there is a 
sufficient record of such practices to warrant legislative action at 
this time, do you? 

Dr. Childress. I have no evidence to suggest that there is. I 
think in a way this would be a preemptive action to avoid some 
problems down the road, in part because of the increased publicity 
about the need for organs. 

We have encountered some proposals for the sale of organs from 
philosophers and lawyers and others — sometimes not only tongue 
in cheek — and perhaps it would be wise to avoid some of the prob- 
lems before they really become serious, again, in view of the in- 
creased publicity about the need for organs. 

Mr. Gore. I understand the State of Georgia has already passed 
such a law. We will take that recommendation under considera- 
tion. I have found that my colleagues and I are becoming increas- 
ingly skeptical of preemptive laws. Your arguments are well put, 
and we will certainly take them under consideration when we go 
through our recommendations. 

Let me thank the two of you for coming here. I always find the 
testimony of bioethicists fascinating and enlightening. I congratu- 
late you on the work that you do. I have been convinced for some 
time, and even more so as chairman of this subcommittee, that the 
debate over bioethics is going to become a routine dialog in this 
country as new medical and biomedical techniques force choices 
upon us that are simply unfamiliar to us. 

Our traditional legal and ethical systems don't equip us to make 
wise choices with respect to these new powers technology has con- 
ferred upon mankind. As a result, the relatively new discipline of 
bioethics has to scramble to keep up. We turn to it often for advice. 
We appreciate your pioneering work in this area. 

Thank you very much. 



374 

The final panel will speak to us about the legal considerations 
involved in this area. We are pleased and honored to have Dr. 
David Wiecking, Office of the Chief Medical Examiner in Rich- 
mond, Va.; Dr. Roger Evans, research scientist with the Health and 
Population Study Center at the Battelle Institute in Seattle; and 
John McCabe, legal counsel with the National Conference of Com- 
missioners on Uniform State Laws, from Chicago. 

Dr. Wiecking, we will begin the panel with you. We are delighted 
to have you here. Without objection, the entire text of your re- 
marks will be included in full in the record. We invite you to 
present that portion of it as you see fit. Welcome. 

STATEMENTS OF DAVID WIECKING, M.D., OFFICE OF THE CHIEF 
MEDICAL EXAMINER, RICHMOND, VA.; DR. ROGER W. EVANS, 
RESEARCH SCIENTIST, HEALTH AND POPULATION STUDY 
CENTER, BATTELLE INSTITUTE, SEATTLE, WASH.; AND JOHN 
McCABE, LEGAL COUNSEL, NATIONAL CONFERENCE OF COM- 
MISSIONERS ON UNIFORM STATE LAWS, CHICAGO, ILL. 

Dr. Wiecking. Thank you, Mr. Chairman, gentlemen. 

The medical examiners in this country are the physicians, many 
of them pathologists, who investigate violent, sudden, and unex- 
pected deaths. Each year in this country there are about 25,000 
homicide victims, 28,000 suicides, and 100,000 accidental deaths, 
50,000 from automobile fatalities. 

Many of these victims of sudden death are otherwise healthy 
young adults who would be excellent organ donors. Unfortunately, 
many of these organs are not utilized for that purpose. It would be 
an excellent idea if there were some system which would permit 
the orderly and expeditious use of transplantable organs from 
those victims. 

The common law of dead bodies in the Anglo-American jurisdic- 
tions indicates that the dead body is the property of the next of kin 
for purposes of a decent disposition. Therefore, we must obtain per- 
mission from the next of kin for an organ harvest. The only signifi- 
cant change in this has been the Uniform Anatomical Gift Act, 
which has already been mentioned this morning. 

Some States put donor forms on the back of the driver's license. 
In theory, it is a good idea. In practice, it often is not found until 
too late. 

Another problem which occasionally occurs from the medical ex- 
aminer's standpoint is that of releasing a donated organ from a 
medical examiner's case even with the express approval of the de- 
cedent or his next of kin. 

Of course, from the medical-legal standpoint, it is important that 
the medical examiner be permitted to perform his statutory duty of 
determining the cause and manner of death without interference. 

The usual problem, however, comes up where an organ is sought 
from a part of the body removed from the area of injury. This, in 
my opinion, should not present any insuperable problem to the 
medical examiner. 

For instance, there is no reason, in my opinion, why a medical 
examiner should be reluctant to release a kidney for transplant 
from the body of a person who has been shot in the head. Occasion- 



375 

ally, it is feared that some astute defense attorney will capitalize 
upon this. I don't think that is a viable objection. 

Some States, as we have already heard, have enacted legislation 
which will permit the medical examiner to take organs from a 
case, presuming in law that the person has consented to the taking 
of the organs, subject to the express disapproval of the surviving 
next of kin; the opting in system, as I understand it. 

This, obviously, would work to the increased number of organs, 
but it has been opposed by certain people from religious and liber- 
tarian viewpoints. I doubt that the majority of Americans would 
object to an opting in system, and I think it would be a very useful 
mechanism. 

The only request from the medical examiner is that the medical 
examiner be notified promptly and without equivocation as to 
whether this person has or has not previously objected to the pro- 
posed taking of the organ. 

Medical examiners in this country have jurisdiction over dead 
bodies pursuant, in the great majority of cases, to State law. The 
Federal Government has very limited jurisdiction over death and 
very few facilities to deal with it. How the Federal Government 
will affect the organ harvest situation is obviously the purpose of 
these hearings. 

It would appear to me that it must come through encouragement 
to the States to change State jurisdictional statutes to give the 
medical examiners the power to obtain these organs when they are 
sought. 

In my opinion, the vast majority — and I would hope all — of the 
medical examiners in this country cooperate with organ procure- 
ment programs and cooperate with transplant surgeons when they 
are requested. It does not mean increasing the number of autop- 
sies. It does not mean changing the criteria for performance of a 
medical-legal autopsy. It means merely saving an otherwise dis- 
carded organ to be used to prolong the life of a living person. 

The medical examiners in this country are ready to help. What 
we need is the statutory immunity and the statutory authority to 
do so. 

Thank you. 

Mr. Gore. Thank you very much. 

[The prepared statement of Dr. Wiecking follows:] 

Statement of Dr. David K. Wiecking, Chief Medical Examiner for the 

Commonwealth of Virginia 

I am Dr. David K. Wiecking of Richmond, Virginia. I am Chief Medical Examiner 
for the Commonwealth of Virginia and Chairman of the Board of Directors and im- 
mediate Past President of the National Assocation of Medical Examiners. The Medi- 
cal Examiners in this country are the physicians, many of them pathologists, who 
perform the medico-legal investigations into violent and suspicious death cases. 
Each year in this country there are approximately 25,000 homicide victims, 28,000 
suicides, and 100,000 accidental deaths, including about 50,000 automobile fatalities. 
Many of these victims of sudden death are otherwise healthy young adults who 
would be excellent organ donors for transplant purposes. Unfortunately however 
from the transplant surgeon's standpoint and even more importantly from the per- 
spective of the patient awaiting the transplanted organ, very few of the transplant- 
able organs from the suddent death victims can be utilized under the present state 
of the common and statutory law. It would be a tremendous benefit to the numbers 
and the success of transplant operations if the transplantable organs from the 
sudden death victims could be utilized in a systematic and expeditious method. 



376 

The common law of dead bodies in the Anglo-American jurisdictions indicates 
that the body of the deceased is the property of the next-of-kin for purposes of a 
decent disposition. The common law states that permission from the next-of-kin 
must be obtained in order for any portions of the dead body to be utilized for any 
other purpose. This notification and receipt of permission requirement causes fre- 
quent problems of time delay which render the sought-after organ useless for trans- 
plant. The only significant change in this common law requirement had been the 
introduction of state legislation of the Uniform Anatomical lift Act, which gives 
the donor the power to direct diposition of his organs when he dies. The Uniform 
Anatomical Gift Act has been a significant help, but there are still many potential 
donors who have not completed donated forms, and others wherein the donation 
form is not discovered until too late. Some States have put the donor forms on the 
back of the driver's license, and while that again theoretically is a good idea it does 
not work too well in practice because too often the driver's license of the deceased is 
not examined or it is examined too late. 

Another problem which occasionally occurs is the reluctance of the Coroner or 
Medical Examiner to release a donated organ even with the express approval of the 
decedent's next-of-kin. From the medico-legal standpoint, it is of course paramount 
that the Medical Examiner or Coronor be permitted to perform his principal 
medico-legal objective, which is the accurate and legally defensible determination of 
the cause and manner of death. Removal of an organ for transplant which interfers 
with the Medical Examiner's statutory duty is not appropriate. The usual situation 
however is that the Medical Examiner is concerned about the injured organs and 
the recovery of bullets and other items of evidence related to the death. The remov- 
al of a useful organ for transplant remote from the area of bodily injury and which 
does not impair the recovery of evidence from the body should not present an insu- 
perable problem for the Medical Examiner. The transplant surgeon will not want an 
organ which has been injured, and the transplant surgeon can always attest to the 
normality of any organ which he has removed and transplanted. The occasionally 
voiced fear that an astute defense attorney will impeach the Medical Examiners' 
testimony because for example, the kidneys have been removed for transplant from 
a gunshot wound to the head case, is not a valid objection to the beneficial purposes 
of organ transplant. 

Some States have enacted legislation permitting the Medical Examiner to take 
organs from the deceased upon the request of a transplant surgeon, presuming in 
law that the deceased and his family would approve, subject to express disapproval 
by the surviving kin. Such a statutory presumption certainly works to the increased 
efficiency of organ procurement and it probably represents the sentiments of the 
great majority of citizens. There are however opponents of such a presumption of 
approval, based on religious and libertarian viewpoints. It is a philosophical ques- 
tion which must be resolved in a rational manner for the betterment of our society 
as a whole. It is doubtful that the majority of Americans would object to the remov- 
al of a viable kidney from a suddenly deceased relative which can be used to pro- 
long the life of another person. It would seem in the public interest to assume that 
such a donation is desirable and to put the burden of objecting to it upon the objec- 
tor. 

Medical Examiners and Coronors assume jurisdiction over dead bodies pursuant 
in the great majority of cases to state and local statutory law. The Federal govern- 
ment has very limited jurisdiction over sudden or violent death cases, and has very 
few facilities to deal with them on a routine basis. How the Federal government 
would implement procedures to expedite organ procurement from such cases is evi- 
dently the purpose of these hearings. It would seem that it must be done through 
encouragement to the States to enact enabling legislation to permit Medical Exam- 
iners and Coroners to obtain transplantable organs during the course of their rou- 
tine statutorily authorized medico-legal autopsies. In my opinion the great majority 
of Medical Examiners and Coroners in this country would be cooperative with organ 
procurement and transplant operators provided they had the statutory immunity 
and authority to harvest the transplantable organs. It does not mean increasing the 
number of autopsies, nor changing the criteria for performance of a medico-legal au- 
topsy, but merely the saving of an otherwise discarded organ to be used to prolong 
the life of a living person. The Medical Examiners of this country are ready to help; 
what they need is the statutory authority. 

Mr. Gore. We would like to hear now from Dr. Roger Evans, the 
research scientist at the Health and Population Study Center at 
the Battelle Institute in Seattle. We appreciate your willingness to 
testify today instead of yesterday, Dr. Evans. Please proceed. 



377 

Dr. Evans. Thank you very much, Mr. Chairman. 

I am very pleased to have the opportunity to testify. Under my 
direction at the Human Affairs Research Centers in Seattle, we are 
currently engaged in two major studies concerning organ trans- 
plantation. These are the national heart transplantation study and 
the national kidney dialysis and kidney transplantation study. 
Both studies are sponsored by the Health Care Financing Adminis- 
tration. 

In developing a prototypical approach to the assessment of 
health care technology, the national heart transplantation study is 
addressing numerous issues we have discussed over the past 2 days. 

These include the need for heart transplantation in the United 
States; the availability of donor hearts; the survival of heart trans- 
plant recipients; the cost of performing a heart transplant and pro- 
viding the routine care required thereafter; the quality of life and 
rehabilitation enjoyed by heart transplant recipients; the legal and 
ethical issues pertaining to the selection of candidates, the procure- 
ment of organs, and the conduct of heart transplantation proce- 
dures. 

The major objective of the study, once the foregoing analyses are 
completed, is to examine the impact of a potential coverage deci- 
sion on the medicare program, transplant beneficiaries, and health 
care providers. 

I might add that we could insert liver transplantation through- 
out. That is what I am trying to refer to by prototypical approach, 
that the issues that we are addressing in the heart transplant 
study are really generic to many health care technologies that 
have emerged today or have existed for some time. 

For purposes of today's testimony, you are undoubtedly most in- 
terested in that component of the national heart transplantation 
study concerning donor organ procurement. First, let me describe 
each of several data collection efforts we plan to undertake. Having 
done this, I would then like to present some results from an infor- 
mal inquiry we have just completed concerning the status of organ 
procurement with regard to the Uniform Anatomical Gift Act, 
brain death laws and organ retrieval procedures throughout the 
United States. 

We have now planned and are about to carry out three separate 
data collection activities on both potential and actual donors. The 
first of these activities amounts to an analysis of existing data in 
an attempt to estimate the total number of people who die in hos- 
pitals each year who satisfy various donor selection criteria and 
thus are potential organ donors. 

Eligible donors, as we have now heard, must be brain dead. It 
has been estimated that as many as 20,000 people die each year in 
the United States who have brain injury, tumor, or infarction, all 
of which may make them reasonable donor candidates. 

To provide a more realistic estimate of the availability of donor 
hearts, we plan to modify the estimates derived through the above 
analyses based upon information we obtain in a second data collec- 
tion effort; that being the potential organ donor survey. 

You may be aware that in 1968 a Gallup poll indicated that 70 
percent of Americans expressed their willingness to donate organs 
for transplantation at the time of their death. We heard yesterday 



378 

and again today that the number has seemed to decline substan- 
tially since 1968 in the recent National Kidney Foundation poll. 
This may be a source of some concern, given the proceedings of this 
meeting. 

In our survey, to be undertaken within the next several months, 
we plan to determine not only people's willingness to donate 
hearts, but also their willingness to donate kidneys, corneas, livers, 
lungs, pancreas, the skin, and bodies. 

As you may be aware, people discriminate in terms of which 
organ they will donate. Some people are willing to donate kidneys 
but are unwilling to donate hearts and corneas, for example, so it 
is important to document each of these. 

Data will also be obtained on age, sex, and various other social 
and demographic characteristics of the respondents. There are var- 
ious characteristics that respondents have that exclude them as 
being potential donors, age being one of the foremost. 

Respondents will be asked to answer questions regarding brain 
death and their willingness to permit organs to be removed from 
their spouse or children if, upon the declaration of brain death of 
the latter, they are found not to be carrying donor cards. 

Finally, we plan to initiate an intense 12-month survey of nearly 
all organ procurement programs in the United States. The purpose 
of this survey is to determine how many actual kidney donors 
could have also been heart donors. 

To better characterize the current state of organ procurement in 
the United States. I would like to take a few minutes to describe 
the results of a recent inquiry my associates and I have completed. 
We were interested in finding out some of the reasons for the con- 
tinuing disparity between the supply and the demand for donor 
organs. 

The interview guide we used focused on the following areas: 
State laws enacted, donor documentation, education and participa- 
tion of public hospital personnel and law enforcement personnel, 
and consent required from decedent's next of kin. 

Our inquiry found that all 50 States and the District of Columbia 
have adopted some form of the Uniform Anatomical Gift Act. We 
found that the majority of the larger organ procurement programs 
were well aware of the provisions of the act. However, some re- 
spondents were unaware of particular variations and a few were 
unaware of the provisions of the act. In addition, many people ex- 
pressed misinterpretations of key provisions of the act. 

DETERMINATION OF DEATH 

We, specifically, asked people about their State statutes that de- 
lineate a definition of death. We found that although only 30 
States have a legislatively determined definition of death, 48 used 
brain death as a standard for death in appropriate cases. 

Whether legally stated or not, the decision to declare death is 
left to the physician, based on common law and the use of medical- 
ly acceptable criteria. In these States, the medical community has 
set forth the criteria that gives structure, consistency, and confir- 
mation to the determination of death. 



379 

The concept of brain death, at least in the medical profession, ap- 
pears to be widely accepted. Thus, legislative recognition of the 
brain death standard does not appear to substantially affect the 
harvesting of organs for transplantation. 

DOCUMENTATION 

The documentation required to indicate a person's wish to donate 
his or her organs varies from State to State. Of primary interest 
were documents that potential donors might carry with them; 
namely, drivers' licenses and organ donor cards. 

Forty-four States have a provision on their permanent drivers' li- 
censes for organ donation. These provisions are optional, meaning 
that the driver has the option of stating his or her intentions re- 
garding organ donation. A variety of methods are used to identify 
potential donors on licenses. 

No State requires drivers to indicate whether or not they are 
willing to donate organs. This is contrary to what was stated yes- 
terday. The State of Colorado, in checking with the attorney gener- 
al's office, does not require a person check the yes or no box. 

At best, drivers are presented with the option of stating their in- 
tentions. In Colorado, where the donor box appears on the face of 
the license, response has been impressive. Out of 1.5 million driv- 
ers, 900,000, that is 60 percent, are designated as donors. 

Other States that place organ donation provisions on the faces of 
their drivers' licenses report fewer designated donors, between 1.5 
percent and 8.5 percent. I believe that the discrepancy with regard 
to Colorado may be a result of misinterpretation. People simply 
feel they must check the box, although we can't be certain at this 
time. 

Another document that may be used to identify potential donors 
is the organ donor card. These cards are generally distributed inde- 
pendently of the drivers' licenses by an organization within the 
State, such as the National Kidney Foundation or the Lion's Eye 
Bank. This form of documentation is available in all but three 
States. 

Although the people we talked with could not provide exact fig- 
ures, they repeatedly emphasized the fact that the percentage of 
donors with cards is very small. One transplant coordinator esti- 
mated that the number of card-carrying donors is 2 or 3 percent of 
all donors at most. Another person reported that out of 600 donors 
in the past 7 years, only 3 had carried donor cards. 

If only such a small percentage of donors actually have cards, 
then what role do donor cards play? Leverage, said many people we 
talked to. When approaching the family, medical personnel and 
transplant coordinators use the card as evidence of the decedent's 
wish to donate his or her organs. It is also used as an educational 
tool, a symbol to promote awareness and discussion of organ dona- 
tion, especially among families. 

When asked how it is determined if a potential organ donor is 
carrying a card, we found no State had a comprehensive procedure 
to be followed by law enforcement and medical personnel who 
might be involved with accident victims. Only one State reported 
that its State police department had an official policy directing its 



380 

force to look for donor cards at the scene of accident and to alert 
hospital personnel if one was found. 

When we asked what action medical personnel would take to 
identify a potential donor, the people we talked to gave a variety of 
responses. The organ-procurement agencies in a few States have es- 
tablished ties with at least one intensive care unit nurse in almost 
every hospital who acts as an organ retrieval coordinator. The 
nurse/coordinator monitors the course of every patient in the unit. 

When a patient's condition is clearly terminal, the nurse ar- 
ranges with the attending physician to have one of them talk with 
the family about organ donation, after the family has been in- 
formed of their relative's prognosis. With this system, almost every 
potential donor is identified and his or her family approached con- 
cerning organ donation. 

Consent. Perhaps the most crucial step in the entire organ dona- 
tion procedure is obtaining consent from the next of kin. If donor 
documents are not available — and the percentage of donors with 
cards is negligible — the Uniform Act authorizes survivors to make 
anatomical gifts of all or part of the decedent's body, unless they 
are aware of contrary intentions by the decedent. 

The first consent question we asked was, "If a card is not found, 
would next of kin be consulted concerning organ donation?" People 
we talked to in 45 States answered yes. This may be the case in 
four other States, but not necessarily. Transplant coordinators ex- 
plained that it depends strictly on the attending physician. In the 
remaining two States, the issue of organ donation is never raised 
with survivors because there are no organ procurement programs 
in the States. 

We also asked who approached the decedent's family concerning 
anatomical gifts. In some institutions, this responsibility lies with 
one person or department exclusively. Generally speaking, howev- 
er, the people we talked to named more than one source. 

Section 2(e) of the Uniform Anatomical Gift Act states, "The 
rights of the donee created by the gift are paramount to the rights 
of others except as provided by Section 7(d) (medical examiners' 
duties)." Given proper documentation, such as a signed donor card 
or marked driver's license, physicians may legally remove organs 
from decedents even if families object. The results of our inquiry, 
however, indicate that this rarely happens. 

With donor documentation available, family consent is still re- 
quired in the vast majority of States. People we talked to in 47 
States said that surgeons require family approval. When presented 
with the hypothetical situation in which the decedent's relatives 
could not be located, only 11 of the 47 States said they would prob- 
ably proceed with organ removal. 

Three major reasons were given for requiring family consent de- 
spite valid donor documentation. In 28 States, people said they rely 
on family confirmation in order to avoid potential legal disputes. 

Ethical considerations are another major reason that next of kin 
consent is required. It is a factor in 25 States where medical per- 
sonnel feel that it is morally wrong to ignore objections raised by 
survivors. 

Finally, 15 States cited fear of bad publicity as a reason for ob- 
taining family consent for organ removal. 



381 

Only four States take full advantage of the provisions of their 
anatomical gift acts. Transplant coordinators in these states ex- 
plained that potential donor intentions, legally documented, cannot 
be vetoed by others. The family is simply informed of the proce- 
dure as a matter of formality. The results of the inquiry reported 
here suggest several areas which should be further addressed in 
the future. 

Clearly there are a number of important issues concerning the 
impact of laws pertaining to anatomical gifts. It is evident that the 
original goal of the measure has not been achieved; that is, the 
Uniform Anatomical Gift Act alone has not succeeded in more 
closely matching supply to demand. Anatomical gift laws have 
been enacted, brain death laws passed, documents distributed and 
medical personnel educated, but the demand still far exceeds the 
supply. 

There is little doubt that a greater number of signed donor cards 
would be likely to increase the supply of donor organs. Transplant 
coordinators across the country emphasized that very few families 
withhold consent when made aware of the decedent's donor docu- 
mentation. 

The fact that only a small percentage of donors actually have 
donor cards raises questions about current methods of document 
distribution. The work of private groups or institutions is limited 
by their own resources and, at best, they can only ask the people 
they reach to consider their cause. 

There are certainly things that can be done to increase card dis- 
tribution, such as making cards available in more hospitals, doc- 
tors' offices and schools, but these efforts cannot reach all groups 
or individuals in the public sector. In contrast, the government not 
only has the greatest access to the public, but also has the capabili- 
ty of devoting substantial monetary resources to the task of pro- 
moting organ donation. 

Should the government play a more aggressive role in promoting 
organ donation? Should it assume the responsibility of at least pre- 
senting the issue to every adult. Every state could do more to 
insure that the organ donor section on the driver's license is more 
than a box that one probably ignores or forgets to fill in. 

People we talked to indicated that the greatest difference among 
programs and hospitals is not in how they identify donors but 
rather how consistently they attempt to do it. Building a network 
of involved, motivated referral sources among medical personnel 
requires a great deal of effort, patience and farsightedness on the 
part of organ procurement agencies. 

The results of our inquiry also suggest that the Uniform Act is 
largely ignored when it comes to matters of consent. Although the 
Act recognizes donor documents as sufficient evidence of the dece- 
dent's intentions and even extends blanket protection to physicians 
who remove organs while acting in good faith, the vast majority of 
medical institutions in this country will not allow organ removal 
without consent from the next of kin. 

Thus, while the philosophy of the act is to carry out the dece- 
dent s wish, the reality is that these wishes cannot be carried out 
until the family approves. Most institutions base this policy on 



23-029 0-83-25 



382 

their fear of prosecution, a definite sign that they feel the protec- 
tion offered them in the Uniform Act is not sufficient. 

Legislation may or may not remove all perceived barriers to ef- 
fective organ procurement. There remains the question of how to 
deal with ethical objections and the fear of bad publicity. Again, an 
important key to the answer is education, both professional and 
public. Organ donation must be presented in a positive light. If the 
attitudes of medical personnel and the general public reflected 
these positive aspects of organ donation, ethica 1 . objections and the 
fear of legal liability and bad publicity would not be seen as such 
serious obstacles. 

I would like to conclude my testimony with some comments on 
the National Kidney Dialysis and Kidney Transplantation Study. 
This study is concerned with the costs and benefits associated with 
various approaches to the treatment of kidney failure, often re- 
ferred to as end-stage renal disease. The purpose of the study is to 
identify which of several treatment modalities is least costly to the 
Federal Government yet, at the same time, is most beneficial to the 
patients being treated. 

I think, at the outset, that we would all agree that cost should 
not be the sole criterion upon which we base our judgment of the 
effectiveness of alternative treatments. Yet, at the same time, we 
recognize that cost is a very important consideration. This has been 
emphasized repeatedly over the past 2 days. 

It is in this regard that kidney dialysis and transplantation raise 
some very difficult questions which we must confront as a society. 
As we now see, these questions have to do with what we might call 
resource allocation and rationing. 

I have thoroughly considered these issues in two papers which 
will appear in the April 15 and April 22 issues of the Journal of 
the American Medical Association. That paper is part of my writ- 
ten testimony. 

In my estimation, we have now reached a point where there is 
what I might call a new medical imperative, that being to develop 
policies and procedures for making resource allocation and ration- 
ing decisions. These decisions, I might add, cannot be left solely to 
physicians; that is, it requires a great deal of involvement on 
behalf of governmental agencies and personnel. 

In 1982 it cost approximately $1.8 billion to treat about 65,000 
patients with kidney failure in the United States. This is up from 
$747 million in 1978. While the actual cost per patient per year for 
treating end-stage renal disease has decreased when adjusted for 
the rate of inflation, rising total program costs have led to a recon- 
sideration of the future viability of the end-stage renal disease pro- 
gram. 

Policymakers are also concerned that the outcomes experienced 
by many patients are unsatisfactory, thus raising questions about 
the overall benefits of the program as well. 

A most difficult question is now being asked. Are ESRD pa- 
tients — that is, people who have kidney failure — truly benefiting 
from long-term maintenance dialysis and kidney transplantation? 

Recently, several studies have shown that the benefits derived by 
many patients are relatively few. Indeed, many patients appear to 
lead unacceptable lives, characterized by frequent hospitalization, 



383 

family discord, and personal catastrophe. Thus, while it cannot be 
denied that the ESRD program has saved lives of patients with 
chronic renal failure, attention is now beginning to focus on the 
quality of their lives. 

In the National Kidney Dialysis and Kidney Transplantation 
btudy, the quality of life of 859 patients randomly selected from 11 
dialysis and transplant centers across the United States, has been 
assessed. These results show clearly that kidney transplantation 
when successful, is a superior treatment alternative to long-term 
maintenance dialysis of any kind. 

At the same time, however, it is evident from our results that 
patients who have experienced a failed kidney transplant have sig- 
nificant medical and rehabilitation problems which distinguish 
them from successful kidney transplant recipients. 

Thus, rather than use the results of this study to promote kidney 
transplantation as optimal treatment modality for end-stage renal 
disease, I remain committed to the position that dialysis and trans- 
plantation must be viewed as complementary, rather than competi- 
tive treatment modalities. 

Over the past 2 days there has been considerable discussion of 
the cost of organ transplantation. Moreover, I would like to under- 
score the fact that the cost of dying with untreated catastrophic 
disease is far less than providing even routine treatment for cata- 
strophic disease; that is, if no attempt is made to reverse the dis- 
ease process upon the diagnosis of a condition, such as biliary atre- 
sia or idiopathic cardiomyopathy, dollars are in a sense saved. This 
was pointed out yesterday by Dr. Starzl, when he was citing the 
study which indicated that the cost of dying was quite expensive. 
As a society, we obviously find it cruel to withhold even routine 
treatment. This has been borne out over the past 2 days. Thus, the 
C0 /} j a trans P lant procedure must be viewed as the marginal 
added costs which are incurred over and above the routine medical 
care that would have been provided regardless of whether or not 
the patient in question received a transplant. 

For example, a patient who does not receive a transplant will 
incur considerable medical expenses, regardless of whether or not 
they receive a transplant. We need to keep this in mind when we 
consider cost. Despite this, however, we must recognize that there 
are truly limits to how much we can realistically do to spare 
human lives from that which is truly inevitable: death. 

For example, is it a wise use of scarce resources to do everything 
imaginable to maintain the life of a patient with a terminal cancer 
whose prospects of living beyond a few months is virtually nil? Are 
these resources not better spent in providing care to other patients 
who are likely to benefit? 

At the same time, we find it especially cruel when representa- 
tives of major government insurance companies, such as medicare, 
medicaid, and CHAMPUS, as well as private insurance companies, 
such as Blue Cross and Blue Shield decide not to pay for proce- 
dures such as heart and liver transplantation. 

Yet, what we often fail to recognize is that these coverage deter- 
minations, as I refer to them, are by no means simple. A consider- 
able amount of data must be amassed and analyzed to better un- 
derstand the implications— financial, legal, ethical, and sociomedi- 



384 

cal — of the decisions we make. This is precisely what we are doing 
for the Federal Government in the Health Care Financing Admin- 
istration-sponsored National Heart Transplantation Study. 

Is it not unusual that at at time when we are considering the 
possibility that the medicare program is likely to go broke we are 
suggesting that coverage be extended to include very expensive life- 
saving therapy, such as liver transplantation, which is estimated to 
cost between $175,000 to $200,000 per procedure? 

Is it net time that we begin to ask how many of these procedures 
can be supported by public funds? I think the ethicists have made 
this point. 

With these remarks I do not intend to suggest that many of the 
costly procedures we have discussed over the past 2 days are not 
worthy of support. Indeed, they are. What I want to suggest is that 
perhaps resource allocations to public health care programs do not 
reflect the priority that the public attaches to them. 

In effect, if the public only wants the finest health care availa- 
ble, as was suggested yesterday, is it truly willing to pay for it? Do 
current allocations to publicly subsidized health care programs re- 
flect this public commitment? In effect, should more resources be 
allocated to health care programs and less to alternative uses? 

Ultimately we must recognize that the Brandon Halls and the 
Jamie Fiskes really serve to epitomize a much larger problem we 
must confront as a society. It clearly goes well beyond the organ 
procurement problem itself. 

There are many people in this world with a variety of medical 
problems which can be treated if we are willing to expend the re- 
quired resources, but since the necessary resources are truly finite, 
we must make what some have referred to as tragic choices. 

It is in making these decisions that we come to recognize that ill- 
ness, despite its tragedy, is part of the human condition, and that 
illness provides meeting and insight into the human condition. 

Thank you. 

[The prepared statement of Mr. Evans follows:] 



385 

ORAL TESTIMONY 
Presented before the 

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT 

of the 

COMMITTEE ON 

SCIENCE AND TECHNOLOGY 

U. S. HOUSE OF REPRESENTATIVES 

on 

April 14, 1983 

by 



Roger W. Evans, Ph.D. 

Research Scientist 

Health and Population Study Center 

Battelle Human Affairs Research Centers 

4000 N.E. 41st Street 

Seattle, Washington 98105 



This testimony has been prepared by Roger W. Evans, Ph.D., Thomas D. 
Overcast, J.D., Ph.D., Lisa E. Bowen, B.S., Marilyn M. Hoe, B.A., 
Cynthia A. Livak, B.A., Karen Merrikin, B.A., Louis P. Garrison, Ph.D. 
and Diane L. Manninen, Ph.D. 



386 



Mr. Chairman and Members of the Subcommittee: 

As a Research Scientist at the Battel 1e Human Affairs Research Centers 
located in Seattle, Washington, I am pleased to testify today. Under my 
direction, the Human Affairs Research Centers is currently engaged in two 
major studies concerning organ transplantation. These are: the National 
Heart Transplantation Study and the National Kidney Dialysis and Kidney 
Transplantation Study. Both studies are sponsored by the Health Care 
Financing Administration (HCFA). 

In developing a prototypical approach to the assessment of health care 
technology, the National Heart Transplantation Study is addressing numerous 
issues including: the need for heart transplantation in the U.S., the 
availability of donor hearts, the survival of heart transplant recipients, 
the cost of performing a heart transplant and providing the routine care 
required thereafter, the quality of life and rehabilitation enjoyed by heart 
transplant recipients, the legal and ethical issues pertaining to the 
selection of candidates, the procurement of organs, and the conduct of heart 
transplantation procedures. The major objective of the study, once the 
foregoing analyses are completed, is to examine the impact of a potential 
coverage decision on the Medicare program, transplant beneficiaries, and 
health care providers. 

For purposes of today's testimony, you are undoubtedly most interested 
in that component of the National Heart Transplantation Study concerning 
donor organ procurement. First let me describe each of several data 
collection efforts we plan to undertake. Having done this, I would then 
like to present some results from an informal inquiry we have just completed 



/ 



387 



concerning the current status of organ procurement with regard to the 
Uniform Anatomical Gift Act, brain death laws, and organ retrieval 
procedures throughout the United States. 

We have now planned and are about to carry out three separate data 
collection and data analysis activities on both potential and actual organ 
donors. The first of these activities amounts to an analysis of existing 
data in an attempt to estimate the total number of people who die in 
hospitals each year and who satisfy various donor selection criteria and, 
thus, are potential organ donors. Eligible donors must be brain-dead. It 
has been estimated that as many as 20,000 people die each year in the U.S. 
who have brain injury, tumor, or infarction, all of which may make them 
reasonable donor-candidates (Council on Scientific Affairs, 1981:2157). 

To provide a more realistic estimate of the availability of donor 
hearts, we plan to modify the estimates derived through the above analyses 
based upon information we obtain in a second data collection effort, that 
being, the Potential Organ Donor Survey. You may be aware that in 1968 a 
Gallup poll indicated that 70.0 percent of Americans expressed their 
willingness to donate organs for transplantation at the time of their death 
(Council on Scientific Affairs, 1981). In our survey, to be undertaken 
within the next several months, we plan to determine not only people's 
willingness to donate hearts, but also their willingness to donate kidneys, 
corneas, livers, lungs, pancreases, skin, and bodies. Data will also be 
obtained on age, sex, and various other social and demographic 
characteristics of the respondents. Finally, respondents will be asked to 
answer questions regarding brain death and their willingness to permit 



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organs to be removed from their spouse or children if, upon the declaration 
of brain death of the latter, they are found not to be carrying donor 
cards. 

Finally, we plan to initiate an intense 12-month survey of nearly all 
organ procurement programs in the U.S. The purpose of this survey is to 
determine how many actual kidney donors could also have been heart donors. 

Now, to better characterize the current state of organ procurement in 
the U.S., I would like to take a few minutes to describe the results of a 
recent informal inquiry my associates and I have completed. We are 
interested in finding out some of the reasons for the continuing disparity 
between the supply of, and demand for, donor organs. The interview guide we 
used focused on the following areas: 

state laws enacted; 

donor documentation; 

education and participation of public, hospital personnel, and 
law enforcement personnel; 

consent required from decedent's next-of-kin. 



In our inquiry we found that all 50 states and the District of Columbia 
have adopted some form of the Uniform Anatomical Gift Act. We found that the 



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majority of the larger organ procurement programs were well aware of the 
provisions of the Act, however some respondents were unaware of particular 
variations and a few were unaware of the provisions of the Act. In addition, 
many people expressed misinterpretations of key provisions of the Act. 
Determination of Death 

We specifically asked people about their state's statutes that delineate a 
definition of death. We found that although only 30 states have a 
legislatively determined definition of death, 48 (94%) use brain death as a 
standard for death in appropriate cases. Whether legally stated or not, 
the decision to declare death is left to the physician, based on common law 
and the use of medically acceptable criteria. In these states, the medical 
community has set the criteria that give structure, consistency, and 
confirmation to the determination of death. The concept of brain death, at 
least in the medical profession, appears to be widely accepted and, thus, 
legislative recognition of the brain death standard does not appear to 
substantially affect the harvesting of organs for transplantation. 
Documentation 

The documentation required to indicate a person's wish to donate his or 
her organs varies from state to state. Of primary interest were documents 
that potential donors might carry with them, namely drivers' licenses and 
organ donor cards. 

Forty-four states (86%) have a provision on their permanent drivers' 
licenses for organ donation. These provisions are optional, meaning that the 
driver has the option of stating his or her intentions regarding orqan 
donation. A variety of methods are used to identify potential donors on 
1 icenses: 



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No state requires drivers to indicate whether or not they want to donate 
organs. At best, drivers are presented with the option of stating their 
intentions. In one state 3 where the donor box appears on the face of the 
license, response has been impressive: out of 1-5 million drivers, 900,000 
(60%) are designated as donors. Other states 4 that place organ donation 
provisions on the faces of their driver's licenses report fewer designated 
donors, between 1.5% and 8.5%. 

Another document that may be used to identify potential donors is the 
organ donor card. These cards are generally distributed independently of the 
drivers' licenses by an organization within the state, such as the National 

Kidney Foundation or the Lion's Eye Bank. This form of documentation is 

5 
available in all but three states. 

Although the people we talked with could not provide exact figures, they 
repeatedly emphasized the fact that the percentage of donors with cards is 
very small. One transplant coordinator estimated that the number of 
card-carrying donors is two or three percent of all donors at most. Another 
person reported that out of 600 donors in the past seven years, only three nad 

carried donor cards. 

If only such a small percentage of donors actually have cards, then what 
role do donor cards play? Leverage, said many people we talked to. When 
approaching the family, medical personnel and transplant coordinators use the 
card as evidence of the decedent's wish to donate his or her organs. It is 
also used as an educational tool, a symbol to promote awareness and discussion 
of organ donation, especially among families. 



391 



Procedures 

When asked how it is determined if a potential organ donor is carrying a 
card, we found no state had a comprehensive procedure to be followed by law 
enforcement and medical personnel who might be involved with accident 
victims. Only one state reported that its state police department had an 
official policy directing its force to look for donor cards at the scene of an 
accident and to alert hospital personnel if one was found. 

When we asked what action medical personnel would take to identify a 
potential donor, the people we talked to gave a variety of responses. The 
organ procurement agencies in a few states have established ties with at least 
one intensive care unit nurse in almost every hospital who acts as an organ 
retrieval coordinator. The nurse/coordinator monitors the course of every 
patient in the unit. When a patient's condition is clearly terminal the nurse 
arranges with the attending physician to have one of them talk with the family 
about organ donation—after the family has been informed of their relative's 
prognosis. 
Consent 

Perhaps the most crucial step in the entire organ donation procedure is 
obtaining consent from the next-of-kin. If donor documents are not available, 
the Uniform Act authorizes survivors to make anatomical gifts of all or part 
of the decedent's body, unless they are aware of contrary intentions by the 
decedent. The first consent question we asked was, "If a card is not found, 
would next-of-kin be consulted concerning organ donation?" People we talked 
to in 45 states (88%) answered yes. This may be the case in four other 
states, but not necessarily; transplant coordinators explained that it 



392 



D 

depends strictly on the attending physician. In the remaining two states, 
the issue of organ donation is never raised with survivors because there are 
no organ procurement programs in the states. 

We also asked who approached the decedent's family concerning anatomical 
gifts. In some institutions, this responsibility lies with one person or 
department exclusively. Generally speaking, however, the people we talked to 
named more than one source. 

Section 2E of the Uniform Anatomical Gift Act states, "The rights of the 
donee created by the gift are paramount to the rights of others except as 
provided by Section 7(d) (medical examiners' duties)." Given proper 
documentation, such as a signed donor card or marked driver's license, 
physicians may legally remove organs from decedents even if families object. 
The results of our inquiry, however, indicate that this rarely happens. With 
donor documentation available, family consent is still required in the vast 
majority of states. People we talked to in 47 states 9 (92%) said that 
surgeons require family approval. When presented with the hypothetical 
situation in which the decedent's relatives could not be located, only 11 of 
the 47 states 10 said they would probably proceed with organ removal. 

Three major reasons were given for requiring family consent despite valid 
donor documentation. In 28 states (55%), people said they rely on family 
confirmation in order to avoid potential legal disputes. Ethical 
considerations are another major reason that next-of-kin consent is required. 
It is a factor in 25 states (49%) where medical personnel feel that it is 
morally wrong to ignore objections raised by survivors. Finally, 15 states 
(29%) cited fear of bad publicity as a reason for obtaining family consent for 
organ removal. 



393 



Only four states (8%) take full advantage of the provisions of their 
anatomical gift acts. Transplant coordinators in these states explained that 
potential donors' intentions—legally documented—cannot be vetoed by others. 
The family is simply informed of the procedure as a matter of formality. 

The results of the inquiry reported here, however, suggest several areas 
which should be further addressed in the future (Oksa and Pasternack, 1981; 
van der Vleit and Koostra, 1982; van der Vleit et al., 1982; Barnes, 1983). 
Clearly there are a number of important issues concerning the impact of 
laws pertaining to anatomical gifts. It is evident that the original goal of 
the measure has not been achieved; that is, the Uniform Anatomical Gift Act 
alone has not succeeded in more closely matching supply to demand. 

There is little doubt that a greater number of signed donor cards would be 
likely to increase the supply of donor organs—transplant coordinators across 
the country emphasized that very few families withhold consent when made aware 
of the decedent's donor documentation. The fact that only a small percentage 
of donors actually have donor cards raises questions about current methods of 
document distribution. The work of private groups or institutions is 
limited. There are certainly things that can be done to increase card 
distribution, such as making cards available in more hospitals, doctors' 
offices and schools, but these efforts cannot reach all groups or individuals 
in the public sector. In contrast, the government not only has the greatest 
access to the public, but also has the capability of devoting substantial 
monetary resources to the task of promoting organ donation. 

Should the government play a more aggressive role in promoting organ 
donation? Should it assume the responsibility of at least presenting the 
issue to every adult? Every state could do more to ensure that the organ 



394 



donor section on the driver's license is more than a box that one probably 
ignores or forgets to fill in. 

People we talked to indicated that the greatest difference among programs 
and hospitals is not in how they identify donors but rather in how 
consistently they attempt to do it. Building a network of involved, motivated 
referral sources among medical personnel requires a great deal of effort, 
patience, and farsightedness on the part of organ procurement agencies. 

The results of our inquiry also suggest that the Uniform Act is largely 
ignored when it comes to matters of consent. Although the Act recognizes 
donor documents as sufficient evidence of the decedent's intentions and even 
extends blanket protection to physicians who remove organs while "acting in 
good faith," the vast majority of medical institutions in this country will 
not allow organ removal without consent from the next-of-kin. 

Most institutions base this policy on their fear of prosecution, a definite 
sign that they feel the protection offered them in the Uniform Act is not 

sufficient. 

Legislation may or may not remove all perceived barriers to effective 
organ procurement. There remains the question of how to deal with ethical 
objections and the fear of bad publicity. Again, an important key to the 
answer is education, both professional and public. Organ donation must be 
presented in a positive light. If the attitudes of medical personnel and the 
general public reflected the positive aspects of organ donation, ethical 
objections and the fear of legal liability and bad publicity would not be seen 
as such serious obstacles. 

I would like to conclude my testimony with some comments on the National 
Kidney Dialysis and Kidney Transplantation Study. This study is concerned 



395 



with the costs and benefits associated with various approaches to the 
treatment of kidney failure. The purpose of the study is to identify which of 
several treatment modalities is (are) least costly to the federal government 
yet, at the same time, is (are) most beneficial to the patients being 
treated. I think, at the outset, that we would all agree that cost should not 
be the sole criterion upon which we base our judgment of the effectiveness of 
alternative treatments. Yet, at the same time, we recognize that cost is a 
very important consideration. 

It is in this regard that kidney dialysis and transplantation raise some 
very difficult questions which we must confront as a society. These questions 
have to do with resource allocation and rationing. I have thoroughly 
considered these issues in two papers which v.ill appear in the April 15, 1983 
and April 22, 1983 issues of the Journal of the American Medical Association . 
In my estimation, we have now reached a point where there is what I might call 
a "new medical imperative," that being to develop policies and procedures for 
making resource allocation and rationing decisions. 

In 1982 it cost approximately $1.8 billion to treat about 65,000 ESRD 
patients in the U.S. (Iglehart, 1982a; 1982b). This is up from $747.2 million 
in 1978. While the actual cost per patient per year for treating ESRD has 
decreased (when adjusted for the rate of inflation) (Lowrie and Hampers, 1981; 
1982; Rettig, 1980a; 1980b), rising total program costs have led to a 
reconsideration of the future viability of the ESRD Program. 

Policymakers are also concerned that the outcomes experienced by many 
patients are unsatisfactory, thus raising questions about the overall benefits 
of the program as well. A most difficult question is now being asked: are 
ESRD patients truly benefiting from long-term maintenance dialysis and kidney 



10 



396 



transplantation? Recently, several studies have shown that the benefits 
derived by many patients are relatively few (Gutman and Amara, 1978; Gutman et 
al., 1981; Rennie, 1981; Tews et al., 1980; Poznanski et al., 1978). Indeed, 
many ESRD patients appear to lead unacceptable lives characterized by frequent 
hospitalization, family discord, and personal catastrophe. Thus, while it 
cannot be denied that the ESRD Program has saved lives of patients with 
chronic renal failure, attention is now beginning to focus on the quality of 
their lives (Editorial, 1980; Editorial, 1981; Caplan, 1981). 

In the National Kidney Dialysis and Kidney Transplantation Study, the 
quality of life of 859 patients randomly selected from eleven dialysis and 
transplant centers across the United States has been assessed. These results 
show clearly that kidney transplantation, when successful, is a superior 
treatment alternative to long-term maintenance dialysis of any kind. At the 
same time, however, it is evident from our results that patients who have 
experienced a failed kidney transplant have significant medical and 
rehabilitation problems which distinguish them from successful kidney 
transplant recipients. Thus, rather than use the results of our study to 
promote kidney transplantation as the optimal treatment modality for end-stage 
renal disease, I remain committed to the position that dialysis and 
transplantation must be viewed as complementary rather than competitive 
treatment modalities. 

Over the past two days there has been some discussion of the cost of organ 
transplantation. I would like to underscore the fact that the cost of dying 
with untreated catastrophic disease is far less than providing even routine 
treatment for a catastrophic disease. That is, if no attempt is made to 
reverse the disease process upon the diagnosis of a condition such as 



11 



397 



idiopathic cardiomyopathy or biliary atresia, dollars are saved. Yet, as a 
society we obviously find it cruel to withhold even routine treatment. Thus, 
the cost of a transplant procedure must be viewed as the marginal additional 
costs which are incurred over and above routine medical care that would have 
been provided regardless of whether or not the patient in question received a 
transplant. For example, a patient who does not receive a transplant will 
incur considerable medical expenses regardless of whether or not they receive 
a transplant. 

Despite this, however, we must recognize that there are truly limits to 
how much we can realistically do to spare human lives from that which is truly 
inevitable—death. For example, is it a wise use of scarce resources to do 
everything imaginable to maintain the life of a patient with terminal cancer 
whose prospects of living beyond a few months is virtually nil? Ar